Veterinarians must act as responsible stewards of veterinary medicines. They must use sound professional judgment to protect animal health and welfare, the environment and public health and consider both short and long-term impacts.
This section identifies the relevant expectations when a veterinarian is considering treating an animal with a veterinary medicine with specific reference to risk management.
Veterinarians must follow these requirements when they use or recommend an unrestricted veterinary medicine or authorise (prescribe) an RVM.
Veterinarians must consider the risk of such use or recommendation 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.
Ensure they are satisfied that the choice and use of the product is justified and appropriate to achieve the intended effect and ensures the welfare of the animal.
Determine and provide the appropriate level of advice and training (if any) to:
- administer the veterinary medicine safely and appropriately
- monitor the effects of treatment on the animals
- make provision for veterinary intervention in the case of adverse effects.
Determine and provide the appropriate level of veterinary involvement (if any) required during and after administration so as to manage the risks.
Provide appropriate advice on how to manage residues and withholding periods in food-producing animals.
Provide advice on aspects such as correct handling and storage.
Provide advice on how to dispose of unused or expired products.
Understanding section 1
The stewardship expectations for RVMs apply to the veterinarian whether they personally use or administer the product, or whether they authorise another person to use or administer the product.
The same expectations also apply to unrestricted veterinary medicines (such as flea shampoo) when a veterinarian or an employee of the veterinary practice is using them or making recommendations to a client or member of the public about them. Veterinarians should ensure that practice employees are competent to make recommendations and that they perform to the standard expected in this Code. Where a veterinarian believes that practice employees are not performing to the expected standards, the veterinarian is responsible for taking steps to address this.
Veterinarians must identify and manage the risks associated with using veterinary medicines. Their treatment should minimise the risk of unexpected harmful consequences to the patient, the owner and the public, as well as to them and their staff.
Justified and appropriate use of veterinary medicines
Justified use means a valid reason exists 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 product and the way it is administered are suitable for the situation.
Competence and training in how to administer the product, recognise effects of treatment, and manage adverse effects
Veterinary medicines are administered to animals to achieve an intended effect. Veterinarians are responsible for ensuring that people who administer veterinary medicines are competent to administer the treatments safely and as directed. Veterinarians are also responsible for providing training where appropriate. Further, they should also be providing advice about the intended effects of the treatment and how to identify and manage adverse effects.
The authorising veterinarian must be satisfied that the veterinary medicine will be administered safely and appropriately, and that it will only be used for the specific conditions authorised. If the veterinarian has doubts, then they should reconsider whether to provide an authorisation or they should provide extra training. The authorising veterinarian must be confident that anyone administering veterinary medicines to animals is competent and capable.
The level of training required will vary depending on the circumstances. Consider the levels of advice required in these scenarios.
Lower level of training required
Higher level of training required
advice to an owner of a cat or dog about administering a tablet
level of supervision required to train an owner in administering insulin injections
level of training required to teach a person to administer an intramuscular antibiotic injection (in a production animal setting)
level of training required to teach a person how to administer nerve blocks so as to disbud calves (in a production animal setting)
Veterinary involvement and oversight during and after administrating the veterinary medicine
The level of veterinary involvement/oversight required during and after administering a veterinary medicine will depend on the particular circumstances and the degree of risk that needs to be managed. Some factors are set out in below.
- type of veterinary medicine (eg, anaesthetic, antibiotic)
- the level of training and experience of the person administering the product
- regulatory requirements for that particular product
- level of monitoring required during and after administration.
- the product is only used to treat the conditions for which it is authorised
- potential risks involved with administration
- route of administration (eg, IV, SC, PO, IM)
- expiry dates of the product
- type of patient and existing condition
- risk of unexpected treatment outcomes
Management of residues in food-producing animals
Veterinarians have a professional responsibility, and a legal responsibility under section 55 (3) of the Agricultural Compounds and Veterinary Medicines Act 1997, to provide information to clients to prevent any residues in primary produce occurring from any animal treated with a veterinary medicine which may contravene the requirements of the Food Act 2014 and the Animal Products Act 1999. Veterinarians and their clients may both be charged with offences under this legislation. Whether or not the veterinarian will be accountable depends on the information they give the client. The veterinarian should document that advice in the client’s records and give a copy to the client. The client should sign the copy held at the veterinary practice.
Veterinarians should 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 a veterinary medicine is being used off-label, then it cannot be presumed that the label information on withholding periods is applicable. The veterinarian will need to consider a suitable withholding period, using their professional judgement and previous experience, technical guidelines, pharmacological knowledge, trial results and pharmaceutical company advice. The veterinarian should consider a default withholding period if they have any doubts.
If a veterinarian determines that an unrestricted veterinary medicine 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 Food Act 2014 and 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.
Impartiality when authorising, selling or recommending veterinary medicines to clients
Clients must be able to obtain, and, equally importantly, know they can obtain an unbiased opinion from their veterinarian on the suitability, safety and efficacy of veterinary medicines for treating particular conditions. Veterinarians must be satisfied that the use of a particular veterinary medicine is necessary to achieve a specific and required clinical effect. Considerations of commercial gain for the veterinarian should not influence the use of a veterinary medicine.
Disposal of expired or unused RVMs, needles and syringes
Hazardous wastes include pharmaceutical waste (bottles, containers, CIDRs, dry cow and lactation mastitis product tubes), and used needles and syringes. These hazardous wastes are a threat to public health, safety and the environment. In clinic waste or waste generated by veterinarians on farm should be disposed of into appropriate containers which meet the relevant Australian and/or New Zealand standards for reusable and non-reusable containers. For example, veterinarians should advise clients on how to:
- return needles and syringes to the clinic
- return unused or expired products to the clinic
- dispose of hazardous farm waste in an on-farm offal pit
- disposal of unused or expired products by flushing them into a sewerage system.
Section 2 sets out the legislative requirements for veterinarians who are using or authorising RVMs. In particular, they must comply with the requirements and expectations of MPI’s ACVM Group in relation to authorisation. These are set out in the current MPI Notice Requirements for Authorising Veterinarians.
When using, selling or dispensing veterinary medicines (unrestricted or restricted) or prescription medicines veterinarians must:
- Follow all relevant legislation, including these Acts and their associated subordinate legislation:
- Comply with the conditions of registration on all registered veterinary medicines. For example, a registered veterinary medicine could have a specific condition of registration (will be stated on the label) that states only a veterinarian can administer it. In that case, a veterinarian is not permitted to authorise (prescribe), dispense or sell this medicine.
- Comply with all ACVM regulatory controls when using exempted veterinary medicines.
- In order to be able to demonstrate compliance with the legislation veterinarians must maintain an up to date inventory of veterinary medicines and prescription medicines and ensure there are appropriate systems to:
- Store products appropriately;
- Report adverse events associated with treatment;
- Maintain the integrity of products;
- Provide security of products;
- Ensure safe handling of products;
- Keep records of all purchases and sales and for dispensing of RVMs;
- Label all RVMs and prescription medicines according to requirements.
Understanding section 2
A veterinarian’s treatment should not cause a detrimental effect to agricultural trade or New Zealand agricultural security. A primary purpose of the Agricultural 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 and veterinary medicines. Veterinarians must comply with the regulatory controls of all veterinary medicines they choose to use, sell or authorise. Inherent in this requirement is the expectation that veterinarians have read the registration conditions and have systems in place to warn them of any changes that might affect how the product is permitted to be used. The Health and Safety at Work Act 2015, among other requirements, identifies an employer’s responsibilities to identify hazards and to take steps to remove or manage them.
Maintaining an inventory of veterinary medicines and prescription medicines
Veterinarians must ensure an inventory of veterinary medicines and prescription medicines is maintained. Keeping an inventory means keeping records and verification of all the activities relating to the receipt, storage and dispatch (including dispensing or breaking-down, if applicable). This includes the following, as applicable:
- training records of staff in relation to handling and supply (dispensing)
- records verifying stock levels
- sales and purchase information
- records of disposal/destruction (if applicable).
Veterinarians should keep records of dispensing, including details identifying product and client, dates and any other details (ideally including batch numbers – see next paragraph) so that they can reconcile stocks on the premises and contact clients when a product is recalled.
Note: Even though tracking batch numbers is sometimes difficult, recording batch numbers is the only way to trace back if a product fails or is recalled.
Storing supplies of veterinary medicine
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 at Work Act 2015 and regulations.
Reporting adverse effects from using a veterinary medicine
Veterinarians are not legally required to report in general, but are expected to report to MPI and to the manufacturer any adverse events from using a veterinary medicine. See Adverse Event Report: Veterinary Medicines.
Maintaining the integrity of a product
Maintaining the integrity of a product means to store, transport, handle or supply it in a way that does not compromise the confidence that the product still complies with the manufacturing specification. 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. If a veterinarian does any of these things, they must accept responsibility for their decision if there are adverse consequences.
Ensuring labelling complies with NZVA guidance
Veterinarians should ensure that the labelling of any RVM or PM when dispensed complies with the New Zealand Veterinary Association (NZVA)‘s Guide to Veterinary Authorising (Prescribing) and Dispensing.
Ensuring security, control and safe custody
Security refers to:
- the requirements for safe custody of controlled drugs as specified in the Misuse of Drugs Act and regulations
- veterinarians maintaining enough security and control of RVMs to ensure RVMs are only used according to a veterinary authorisation or veterinary operating instructions (VOI)
- veterinarians ensuring non-veterinarian staff do not sell RVMs without appropriate authorisation.
Safety of handling refers to the responsibilities that apply under the Health and Safety at Work Act 2015.
Section 3 sets out who is authorised to purchase and use RVMs, and how that authorisation works.
Veterinarians who are registered with the Veterinary Council and hold a current annual practising certificate are specifically recognised to purchase and use RVMs by the Director General of the Ministry for Primary Industries (MPI) as set out in Requirements for Authorising Veterinarians.
Actions that veterinarians must take when using or authorising restricted veterinary medicines:
- Comply with the requirements and expectations of the MPI in relation to authorisation. This is set out in MPI’s published ACVM Notice Requirements for Authorising Veterinarians dated 28 August 2015.
- Comply with all points in sections 1 and 2 of the Veterinary Medicines section of this Code.
- Only authorise RVMs following a veterinary consultation, or issuing VOI as detailed in section 4.
- Only authorise PMs or controlled drugs following a veterinary consultation.
- Honour requests that ask for written authorisations instead of dispensing.
- Decide, when authorising RVMs and PMs, the most appropriate period of supply for each product authorised after considering the maximum periods of supply. The following maximum periods of supply apply for authorisations:
- 3 months for PMs
- 6 months for RVMs for companion animals other than horses
- 4 months for critically important antibiotics
- 12 months for all other RVMs for production animals and horses.
Within the above limits the actual period of supply chosen will depend on the particular RVM/PM, the condition being treated, and the risks that need to be managed.
Understanding section 3
Veterinarians should be familiar with the MPI ACVM Notice: Requirements for Authorising Veterinarians dated 28 August 2015. This document sets out MPI’s expectations for veterinarians who authorise the purchase and use of restricted veterinary medicines (RVMs).
When authorising the use of an RVM the veterinarian must have gathered sufficient information to support their decision. They must ensure use is justified, the RVM will be used appropriately and that all risks are managed. A veterinary consultation is the main method to ensure that expectation is met.
MPI sets out in the Requirements for Authorising Veterinarians that records relating to authorisations must be kept for 5 years. Particular expectations about the quality of records are identified in the VCNZ Competence Standards and Performance Indicators. This Code also requires that veterinarians keep and maintain clinical records.
Consultation has several aspects. For a more detailed breakdown of what is expected in obtaining, recording and analysing information, see Competency Standards and Performance Indicators for Veterinarians.
What the Veterinary Council of New Zealand (VCNZ) considers 'sufficient information' (as set out in the definition of veterinary consultation), and whether the consultation process is adequate depends on each situation. Factors taken into account include the generally accepted standard of care that exists for this set of circumstances. A good yardstick would be the decisions or actions another veterinarian with the same training and experience would reasonably make or take in the same situation.
Sometimes VCNZ will publish statements setting out what is considered reasonable for specific situations. One example is the VCNZ Statement on the Information Requirements for Authorisation of Dry Cow Therapy. This sets out the minimum requirements for authorising dry cow therapy.
When RVMs 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 veterinarian will apply the requirements of consultation to the herd or flock collectively rather than to each animal in the herd or flock.
In certain situations it is acceptable for the veterinarian providing the authorisation not to have recently examined or seen the animals as part of a consultation.
One example is the authorisation of a veterinary medicine for a client by a veterinarian employed in the same local practice where:
- that co-worker works in the same area of practice as the client's usual veterinarian; and
- the usual veterinarian would have otherwise authorised the veterinary medicine because they had recently seen the animal and so have personal knowledge of its status, including its health condition.
Few other situations apply where not seeing or examining the animal is acceptable.
Authorisation for future supply
Following a veterinary consultation, a veterinarian may authorise RVMs for future supply. This means the RVMs are authorised to be used in line with specific instructions on specified animals in specific situations beyond immediate use requirements. When authorising RVMs for future supply in production animals, veterinarians must have enough current knowledge of the health status of the animal(s) to ensure that the ongoing use and choice of RVMs remains appropriate and necessary. Veterinarians should obtain enough information through the period of supply of the authorisation to ensure that the circumstances have not changed. For example, they can get updates from the client, get reports from technicians who have worked on the farm, electronic means, and or review farm records.
Farmers are responsible for managing the inventory of authorised RVMs on farm and for ensuring that they only have product on hand that hasn’t expired. Farmers should not have any RVM on their farm unless the RVM is linked to a current and valid authorisation. To help farmers, veterinarians must provide information about the products they authorise, and consider what products are already on the farm before authorising more.
Before authorising RVMs for future supply, veterinarians should request and review information from the farmer about what stocks of products are already on farm, and the expiry dates of that stock. Further detail about the documentation to provide for newly authorised RVMs is in section 5 of the Veterinary Medicines section of this Code.
The period of supply for some product classes may be shorter (for example, four months for critically important antibiotics). Veterinarians must keep this in mind when setting out their authorisations (see section 6 of the Veterinary Medicines section of this Code).
The authorising veterinarian must identify in the consultation record the competencies needed to administer the authorised RVMs correctly.
The veterinarian must make available to the client a printed summary of all the RVMs authorised for future supply to the client. This summary will identify:
- details of each specific product
- the class of animals to be treated
- what the product is to be used for
- the amount of product authorised for the period
- the period of supply
- the amount that can be dispensed for each time and the period between dispensing
- the instructions for use
- storage instructions and information about withholding periods.
Veterinary practices need systems in place to create alerts when authorised amounts are exceeded. In situations where an authorisation for supply exists for an RVM but the quantity is exceeded:
- Staff must make every effort to contact and obtain a veterinarian’s authorisation to be able to dispense more of the RVM.
- In situations where a veterinarian’s authorisation cannot be obtained within a reasonable time, staff may dispense enough of the RVM to manage the existing issue. However, they must advise the veterinarian as soon as possible, and the veterinarian must follow up with the client.
- Staff must not dispense critically important antibiotics in the absence of a veterinarian when an authorisation is exceeded. A veterinarian must always be consulted before critically important antibiotics are dispensed where an authorization has been exceeded.
The documented summary provided to the client is not an authorisation which could be taken to an approved seller to allow the purchase of RVMs.
Electronic authorisation (telemedicine)
Veterinarians using electronic means to authorise the use of veterinary medicines 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.
Two requirements apply when the authorisation of an RVM follows an electronic consultation. First, the veterinarian must have seen the animal(s) recently enough to have enough personal knowledge of its condition/health status so they can propose the particular course of treatment. Second, the veterinarian must be satisfied that a direct physical examination would not add critical information about the management of the case.
Where there has been a consultation and a veterinarian has proposed treatment with a veterinary medicine, the client can request the veterinarian provides them with a written authorisation to have the product dispensed by an MPI-approved seller of RVMs rather than by the consulting veterinarian. The consulting veterinarian must comply with that request. The expectation is that this would apply in every situation where the veterinarian would have otherwise dispensed the trade name product.
A veterinarian is not required to provide a written authorisation for a client to take away to be dispensed somewhere else in a situation where that particular product would not normally be dispensed. One situation is where the veterinarian would normally administer the product themselves so as to manage the risks associated with use; or where an adequate consultation has not occurred. Another situation is where the client is requesting a specific product but the veterinarian believes an alternative product is more appropriate.
The veterinarian should provide the written authorisation to the client within 48 hours except in exceptional situations.
The veterinarian writing the authorisation (not the trader ultimately dispensing the product) is responsible for meeting all the requirements in sections 2 and 3 of the Veterinary Medicines sections of this Code.
Veterinarians can dispense RVMs to their clients but must get MPI approval to dispense RVMs authorised by another veterinarian not employed in their veterinary practice.
Veterinarians can charge a reasonable fee for writing the authorisation. However, it is unethical for a veterinarian to require the client to meet a different standard of consultation before they can get a written authorisation compared to the standard of consultation normally required if the veterinarian dispenses the product. An example might be making the client undertake further diagnostic work following a request for a written authorisation when such work is not considered necessary for the veterinarian to dispense the product in the first place.
The requirement for veterinary authorisation is removed where the use of an RVM is allowed according to an operating plan approved under section 28 of the Agricultural 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 RVMs, an approved plan describes the situations when a specified veterinary medicine will be used by specified people who are not veterinarians to achieve identified treatment objectives. The operating plan provides the statutory basis for the authorisation of the RVMs, and removes the requirement for veterinary authorisation.
Operating plans approved under section 28 of the Agricultural Compounds and Veterinary Medicines Act 1997 are not the same as VOI.
Section 4 discusses veterinary operating instructions (VOIs). These are written instructions for a specified person(s) to hold a specified RVM in anticipation of use to carry out a specified task on a specified animal(s) or class of animals.
RVMs identified in the VOI can only be used for the specified purpose documented in the VOI. Veterinarians are not obliged to issue VOIs; it is up to the discretion of each veterinarian.
MPI’s Veterinary Operating Instructions Guidelines state that the guidelines are not mandatory. However, VCNZ’s expectation is that veterinarians must follow them.
Actions that veterinarians must take when issuing VOIs:
- Comply with the requirements and expectations of MPI in relation to VOIs as set out in MPI’s guidance document.
- Undertake sufficient monitoring (which is recorded) so that they are confident that the terms of the VOI are being complied with
- Withdraw the VOI immediately in situations of non-compliance.
- Do not use VOIs to authorise the use of RVMs when veterinary diagnosis and judgement are required.
- Do not use VOIs to authorise the use of any controlled drug as defined in the Misuse of Drugs Act 1975.
Understanding section 4
Veterinary operating instructions are used in limited situations
VOIs are only used in cases that require no veterinary involvement to decide if an RVM should be used. This means they are only appropriate in those situations where no veterinary diagnosis or veterinary judgement is required when deciding to use the RVM. Treating a bacterial infection does require a diagnosis and judgement about the choice of antibiotic, dose, route of administration, period of treatment. This means a VOI would not be appropriate.
VOIs are generally used to authorise the use of RVMs on animals that do not belong to that veterinarian’s clients. VOIs don’t require a veterinary-client relationship between the veterinarian and the owner of the animals to be treated. This means that VOIs can be issued for RVMs to carry out procedures on other veterinarian’s clients’ animals (such as disbudding by third party eg a contractor).
A VOI is not needed when veterinarians are dispensing RVMs to their own clients to use on their own animals. An authorisation is used instead.
No list is available of which RVMs can and cannot be issued under a VOI. Even so, VOIs should not generally be used for antibiotics as veterinary involvement is required as part of good antimicrobial stewardship. An exception might include prophylactic use, where no veterinary diagnosis or veterinary judgment is required (such as AI programmes, or grooms travelling with horses by air or sea).
VOIs must not be used for controlled drugs. Under the Misuse of Drugs Regulations, veterinarians can only prescribe controlled drugs for animals under their care. This means VOI cannot be used as a mechanism for authorising the use of controlled drugs. The penalties for non-compliance with the Misuse of Drugs Act and Regulations can be severe. This does not limit the authorisation of controlled drugs following a veterinary consultation.
Declining to issue a VOI if concerned that the procedure will have a negative outcome on the animal’s welfare
If a veterinarian is concerned that the procedures that a layperson will undertake may result in negative animal welfare outcomes (such as a lay equine dentist removing an animal’s tooth), the veterinarian should not issue the VOI.
Identifying possible adverse events and deciding how best to manage them
Veterinarians must identify possible adverse events and decide how best to manage them. The person(s) authorised under the VOI must be appropriately trained to manage events that can be reasonably handled without veterinary involvement. Veterinary intervention will be necessary to appropriately manage certain adverse events. In those situations, the VOI must define how that veterinary involvement will be provided. Unless veterinary care in such events is readily available, it may not be appropriate to issue a VOI. The authorising veterinarian will either need to provide that care themselves, or make prior arrangements with other veterinarians so that the service is readily accessible when needed.
Defining an end date or review date for each VOI
VOIs must define an end date or review date. That date must be no more than 12 months from the date the VOI started.
Writing a VOI for use on animals not in the same location as the authorising veterinarian
VOIs may be written to be used on animals not in the same regional location as the authorising veterinarian. In these situations, authorising veterinarians should keep in mind that meeting all their VOI responsibilities may be hard (such as supervising the VOI or managing adverse events). So a VOI is probably not appropriate. Veterinarians are advised to seek advice from VCNZ.
Various reasons for using a VOI
Some examples of how a VOI might be used in practice are:
- prophylactic treatment of healthy animals for the purpose of preventing disease (such as vaccination of animals admitted to a shelter organisation for the purposes of adoption)
- Analgesia of healthy animals to allow for a procedure or manipulation (such as the use of local anesthetic for disbudding calves)
- treatment of any animal identified as having a particular condition or state of health that is clearly described in the VOI so as to justify the use of an RVM listed in the VOI (such as sedation of an agitated horse by a groom on an export flight or shipment).
Ensuring the person identified in the VOI is trained and competent to use the specified RVM
The veterinarian must be satisfied that any person identified in the VOI is competent to use the specified RVM and can carry out the instructions as documented. The veterinarian or another person may have to train the person specified in the VOI or assess their competency. Where VOIs are renewed, the veterinarian must be satisfied that the person is still competent. This may require a reassessment of their competency as part of the renewal process.
Keeping accurate and detailed records
Veterinarians should ensure that any person identified in the VOI keeps accurate records of the use of the RVMs specified in the VOI. These should include the details below.
- how, when, where and on whose animals RVMs were used and in what situations
- volume or amount of product used
- date of use
- method of administration
- name and address of person in charge of the animals
- reason for use
- identity of the animals (or herd or flock)
- adverse reactions or events
- identity of the person using or providing the RVM
- enough details to allow immediate stock reconciliation
Determining the level of monitoring and auditing needed to ensure compliance with VOI terms
Veterinarians must use their professional judgement to determine the level of monitoring and auditing needed to be confident that the terms of the VOI are being complied with.
As part of this monitoring, the veterinarians must examine the records of use so they are satisfied the treatment decisions of the specified person are valid and comply with the VOI terms. The veterinarian will decide how often the records need examining based on the particular circumstances. Veterinarians must reconcile all RVM purchases and disposals against the record of use often enough for them to be confident that product use still complies with the VOI terms. Veterinarians must reconcile RVM use at least every 6 months, or at the end of the VOI term if that is a shorter timeframe.
Written authorisation required if the user does not purchase the RVM from the issuing veterinarian
If the user specified in the VOI does not purchase the RVM from the issuing veterinarian, a written authorisation is required for the user to purchase it from an approved seller of RVMs. While the VOI might be issued for up to 12 months, the veterinarian may choose to provide authorisations for purchase for shorter timeframes. This will allow for monitoring and ongoing auditing to ensure use complies with the VOI terms.
VOIs do not need MPI approval and are not routinely audited
MPI does not need to approve VOIs. Also, VOIs are not routinely audited. A veterinarian may need to produce them after an adverse outcome or for some other reason (such as an on-farm audit).
Section 5 discusses the requirements for records and documentation associated with authorising or using prescription medicines (PM) and RVMs.
- Veterinarians must record every instance of the authorisation of a PM or RVM in a way that links their decision to use the PM or RVM to:
- the animal or group of animals (for example, herd or flock)
- the client
- the authorisation
- the authorising veterinarian.
- Veterinarians must facilitate the traceability of RVMs that have been authorised for use in production animals:
- They must ensure through their own clinical records; records of written authorisations they have provided to clients; and labelling of products they have dispensed that the treatment of an individual animal can be linked back to a specific authorisation.
- Provide the farmer with a documented summary of each product they have authorised at the time of authorisation, including those authorised for future supply. Consider using Appendix 4 of NZVA Guide to Veterinary Authorising (Prescribing) and Dispensing to model the summary of RVMs authorised for future supply provided to the client.
- Ensure the information in their clinical records complies with Section E (7) of NZVA Guide to Veterinary Authorising (Prescribing) and Dispensing Section.
- Where an external written authorisation is provided to the client to be filled by an MPI approved seller for RVMs, or a pharmacy for PMs, its form must comply with the requirements as set out in the NZVA Guide to Veterinary Authorising (Prescribing) and Dispensing Section D(3) for PMs, and Section E(6) for RVMs.
- Label all products where a PM or RVM is authorised by a veterinarian and then dispensed by the veterinarian’s practice to the client. Follow the labelling guidance set out Section E(8) of the NZVA Guide to Veterinary Authorising (Prescribing) and Dispensing.
Understanding section 5
The MPI Requirements for Authorising Veterinarians sets out the ACVM requirements for veterinarians including:
- keeping records of veterinary authorisations for five years
- recording the decision to authorise and that the record must provide enough information to link the RVM to the client, the authorisation and the authorising veterinarian
- ensuring the record is easily accessible
- The form the record takes is at the discretion of the authorising veterinarian. It could be a clinical record, diary entry for the consultation, visit log, invoice, a combination of these records or whatever the veterinarian uses to record the decision according to accepted standards and as appropriate in the circumstances.
The requirements for documentation apply to all practising veterinarians, whether they work in production animal practice or companion animal practice.
Some clients (particularly farmers) are subject to audits of RVM use. In order to facilitate a client’s ability to keep their own records and be able to provide the necessary information when faced with an audit of their RVM use, veterinarians must provide them with a written summary of all RVMs they have authorised for future supply at the time of the authorisation. Veterinarians can use Appendix 4 of the NZVA Guide to Veterinary Authorising (Prescribing) and Dispensing as a template. To help farmers comply with on-farm audits of RVM use, veterinarians must be able to provide copies of all invoices of RVMs supplied when requested.
The copy of the summary of RVMs authorised for future supply provided to the farmer is not, and cannot, be used by the client as an external authorisation/prescription to be filled by an RVM trader.
Section 6 sets out the use of antibiotics so as to encourage prudent use and minimise the risk of antibiotic resistance.
Prudent antibiotic use is about maximising the chances of successful treatment while minimising the development of resistance.
Actions veterinarians must take to ensure they use antibiotics correctly:
- Comply with sections 1 to 5 of the Veterinary Medicines section of this Code
- Limit antibiotic use to those situations where the treatment is necessary to protect the health and welfare of the animal.
- Do not use antibiotics routinely for prophylactic or metaphylactic purposes in place of good clinical or animal husbandry practices.
- Consider using microscopy, a culture or both to identify the type of bacteria in situations where such tests are practical (in terms of time and resources), and likely to provide clinically useful information, before deciding to use or authorise an antibiotic.
- Select the most appropriate antibiotic after considering factors such as:
- the likely bacteria to be treated
- the spectrum of activity of the antibiotics available (the narrower the better)
- the ability to achieve therapeutic concentrations at the site of infection
- the immune status of the patient
- any concurrent diseases of the patient
- the age of the patient
- the physiological status of the patient.
- Consider whether any other evidence-based treatment or management option might be an alternative or adjunctive treatment to antibiotic therapy or might be used to increase the chances of a successful outcome (such as antisepsis, wound drainage, and vaccination).
- Be able to justify (registration label instructions or contemporary independent peer reviewed studies) their prescribing decisions relating to dose rates, duration of therapy and routes of administration.
- Document clearly in the clinical record the reason for deciding to use a particular antibiotic.
- Limit the period of supply for critically important antibiotics in an authorisation to 4 months.
- Do not advertise products containing antibiotics to clients.
Actions veterinarians must take to ensure they use Critically Important Antibiotics correctly:
- Comply with points 1 to 10 above.
- Restrict use to situations where first line antibiotics have been shown to be ineffective.
- Restrict use to cases supported by bacteriological tests or where the prescribing decision is supported by studies or references that are recent and independently peer reviewed.
- Do not use critically important antibiotics as preventive treatment in feed or water in the absence of clinical signs in the animal to be treated.
- Limit off label use for instances where no suitable alternatives are available.
Understanding section 6
Principles of prudent antibiotic use include:
maintaining stricter veterinary oversight when antibiotics are authorised and used
- restricting prophylactic and metaphylactic use of antibiotics
- restricting antibiotic use to situations where the veterinarian believes a bacterial infection in the animal(s) needs treating
- reserving the use of critically important antibiotics
- using other strategies to prevent disease (one strategy is vaccination)
- following recommended dose rates and duration
- helping to ensure the public is educated about responsible antibiotic use.
Veterinarians must document their reasons for deciding to use a specific antibiotic
Veterinarians must document in the record their reasons for deciding to use the antibiotic. They must document the diagnosis (confirmed or suspected) and the results of any diagnostic tests that led to the decision for treatment, the name of the product and details about administration.
Veterinarians must only use antibiotics when needed to protect the animal’s health and welfare
Veterinarians must only use antibiotics in situations where antibiotics are needed to protect the animal’s health and welfare. Two examples of bacterial infections that may not need antibiotic treatment are:
- uncomplicated infectious canine respiratory disease complex (kennel cough)
- uncomplicated balanoposthitis.
Veterinarians should not use antibiotics in clinical cases that do not involve bacterial infection, such as:
- idiopathic cystitis in cats
- primary viral upper respiratory infections in cats.
Veterinarians must consider other strategies that reduce or remove the need to use antibiotics
Veterinarians must consider whether they can use other evidence-based clinical or management strategies to reduce or remove the need to use antibiotics. Two strategies are:
- applying aseptic principles for surgery and good surgical technique so that the need for peri-operative antibiotic use is minimised
- using an antiseptic treatment (such as a shampoo) or topical applications as an alternative to systemic antibiotics for skin conditions.
Veterinarians must understand when it is appropriate to use antibiotic prophylaxis and antibiotic metaphylaxis
Antibiotic prophylaxis refers to the treatment of animals with antibiotics in the absence of disease. It is a preventive form of use where the probability of disease is considered particularly high and where it has been considered successful in reducing the incidence of certain diseases (such as reducing mastitis in the dairy cow through the use of dry period antibiotics protection, called DCT). Antibiotic prophylaxis may also be considered an important treatment in certain situations for individual patients (such as perioperative use in immunocompromised patients). If a veterinarian chooses to use antibiotics prophylactically, choice of antibiotic, route and timing of administration are all critical. As such, the veterinarian should use evidence-based studies to support their treatment decisions.
Antibiotic metaphylaxis refers to the treatment of herds and flocks with antibiotics if they are considered at risk of suffering an outbreak of infectious disease due to exposure to disease agents or unfavourable host or environmental conditions. A certain level of disease may already be present; treatment is to prevent further animals becoming infected and to treat any animal that may suffer infection yet shows no obvious signs of disease. Such an animal would not normally be treated because they cannot be diagnosed. Yet, it exposes all other animals to infection and can lead to significant episodes of disease. In such cases, the veterinarian should justify and document the treatment on the basis of clinical findings and the development of a disease in a herd or flock.
Veterinarians should never use antimicrobial metaphylaxis in place of good animal husbandry and management practices.
Veterinarians should know when to consider first line or empirical therapy, and when to consider second line therapy
First line or empirical therapy involves the use of an antibiotic without knowing the type of bacteria involved or its sensitivity. Common first line antibiotics include penicillin; amoxicillin/clavulanic acid; 1st- and 2nd-generation cephalosporins; tetracyclines and trimethoprim-sulphonamides. The spectrum of activity of the antibiotic should be appropriate for the suspected infection and as narrow as possible
Second line antibiotic therapy can be considered when culture and sensitivity testing, together with patient and infection factors indicate that no first-line drugs are reasonable treatment options. Where culture and sensitivity testing show several antibiotics would be effective, the veterinarian should choose the antibiotic considered most suitable for the situation and least likely to produce clinically significant resistance. Second line antibiotics may include critically important antibiotics. The use of these antibiotics is restricted because they are considered more important in treating serious bacterial infections in humans, or because of concern about the development of antibiotic resistance. A veterinarian should not use critically important antibiotics empirically without good justification. For example, their use of antibiotics is supported by studies that are recent and independently peer reviewed. There must be a legitimate and sound clinical rationale which is evidence based and where dose rate and route of administration is consistent with label instructions. It is not sufficient to authorise the use of an antibiotic because a client requests the product or for reasons of convenience, ease of use and withholding periods. Veterinarians must demonstrate that they are acting appropriately as risk managers when authorising these products empirically. Three scenarios are noted below:
Swabs have been sent to the lab for culture and sensitivity from 5 horses from the same stable with the same clinical symptoms. Results indicate the need to treat with a Critically Important Antibiotic. A sixth horse from the same stable develops the same symptoms.
These results would provide a sufficient epidemiological background to support treating the sixth horse with the same antibiotic. However, this would not be sufficient to justify the same treatment in a horse with the same symptoms from a different stable.
A veterinarian cannot treat a cow with a 3rd or 4th generation cephalosporin after a difficult calving just because they are not confident in the client’s ability to administer daily injections.
The same principle applies to the treatment of a cat with a bite wound abscess with a long acting 3rd or 4th generation cephalosporin.
Bacteriological testing and evidence that appropriate first line or empirical therapy is insufficient are needed.
An experienced farmer has a sick cow with severe mastitis in multiple quarters where the cow is likely to die before the results of bacteriological testing are available.
In an emergency like this, the decision to treat empirically with tylosin might be justifiable if samples are collected for bacteriological testing so that the infection can be identified to help in making decisions should the emergency occur again.
Veterinarians should advise their clients to use antibiotics responsibly
Veterinarians should keep clients informed about the importance of using antibiotics responsibly. They should emphasise the importance of complying with instructions for use. Veterinarians should consider choosing acceptable dosing regimens that are achievable for the animal’s owner (such as combining antibiotics with food or providing them in a liquid or paste form).
Veterinarians must not advertise the sale of antibiotics to their clients
Veterinarians must not advertise the sale of antibiotics to their clients as this has the potential to impact on authorising decisions.
Veterinarians should not use a request from a client as the basis for deciding whether to use an antibiotic
Veterinarians should base their decision to authorise the use of any particular antibiotic product based on the clinical need following a veterinary diagnosis rather than on a request from a client.
Section 7 sets out the minimum protocols that veterinarians must follow when receiving, storing and reconciling any controlled drugs.
The requirements of this section are the minimum professional requirements for veterinarians regardless of any exemptions given to veterinarians in the Misuse of Drugs legislation.
Actions veterinarians must take to ensure they have the appropriate minimum protocols in place:
- Ensure that protocols exist in their veterinary practice to securely receive, store and reconcile the use of any controlled drugs used.
- Store all controlled drugs as set out in section 28 of the Misuse of Drugs Regulations 1977.
- Record every instance of sale or use of a controlled drug and link its use to the date, amount and type of drug, client and authorising veterinarian.
- Use a controlled drug register to record the use and purchase of specific classes of controlled drugs and for reconciling stock. Drugs that need reconciling are Schedule 1 (Class A), Schedule 2 (Class B) and Schedule 3 (Class C) Part 4 controlled drugs. The register can be in electronic format, manual format or both formats.
- Reconcile controlled drugs at least monthly. Reconcile the opening stock, closing stock, purchases and sales for every strength of each type of controlled drug as identified in 4 above.
- Check that the stock remaining is always the same as the calculated balance. Investigate any volume or amount not accounted for in the reconciliation. Ensure documented procedures are in place to help resolve discrepancies.
- Discuss with VCNZ any significant unexplained variances in the reconciliation that cannot be explained or are thought to be due to suspected diversion.
- Keep reconciliation records for 4 years.
Table 1: Electronic vs manual format of the register
Electronic format of the register
Register is printable on request.
Entries on each page relate to only one form or strength of one controlled drug.
Each line relates to one use of the controlled drug.
Each line contains the same information as would be in the manual report, including the calculated Balance.
Manual format of the register
Register is printed as a bound volume.
Pages are numbered consecutively.
All columns are as described in Form 1 Schedule 1 of the Misuse of Drugs Regulations 1977
Entries on each page relate to only one form or strength of one controlled drug.
Each line relates to one use of the drug.
For each line, the information required for each column is recorded, including the Balance.
Table 2: Reconciliation of electronic vs manual formats
Electronic format is used to record transaction of controlled drugs
A report is generated on the day of reconciliation.
Report is reconciled each month.
The report has an entry for the actual stock of each controlled drug.
The actual stock is reconciled against the calculated balance.
A copy of the report showing the reconciliation for each drug is saved and stored either electronically as a PDF (or equivalent), or as a printed hard copy.
A copy of the report is available on request.
Manual format is used to record transaction of controlled drugs
A line is entered on each page, and dated to record the actual stock of the controlled drug.
The actual stock is reconciled against the calculated balance at that date and time.
Understanding section 7
All controlled drugs are either registered as PM (under the Medicines Act 1981) or as RVM (under the Agricultural Compounds and Veterinary Medicines Act 1997). The Misuse of Drugs Act 1975 and the Misuse of Drugs Regulations 1977 specifically apply to all controlled drugs.
To authorise the use of controlled drugs for the treatment of animals, veterinarians must comply with sections 1, 2, 3 and 5 of the Veterinary Medicines sections of this Code. Veterinarians must have met the requirements for consultation and have created and maintained appropriate records detailing the treatment decision.
Controlled drugs are classified as classes A, B or C and then subdivided into sub-classes. The classification is based on the assessment of risk of harm the drug poses to individuals or to society when misused. Schedules 1 to 3 of the Misuse of Drugs Act 1975 identify those particular drugs in each class. Veterinarians are expected to know which controlled drugs (and which trade-name products containing controlled drugs) are used in their veterinary practice, and to know what is required to comply with the legislation and this Code.
Reconciliation is expected for Class A and Class B controlled drugs because these are described as having a “very high risk” and a “high risk” respectively. While a number of Class C controlled drugs are commonly used in veterinary practice, those listed in Part 4 of the Act are considered most at risk in the context of veterinary practice in this Class and therefore need a higher degree of stewardship. Reconciliation of Class A, Class B and Class C part 4 controlled drugs includes (but is not limited to) the following commonly used controlled drugs: morphine, methadone, pethidine, fentanyl, buprenorphine, ketamine and pentobarbital.
Storing controlled drugs
Section 28 of the Misuse of Drugs Regulations 1977 sets out the legal requirements for the custody of controlled drugs. The regulations apply to any person in possession of any controlled drug for the purposes of sale or for use in the course of their profession.
Controlled drugs must be stored properly to avoid unauthorised access. No members of the public (including family and friends) should have access to them. Staff and contractors employed by the veterinary practice should be allowed access only as appropriate.
All veterinarians must be aware of the protocols in their veterinary practice that cover the receipt, use, storage, security and reconciliation of controlled drugs. All staff must be aware of and comply with those protocols. While veterinarians have overall responsibility for the controlled drugs, many of the tasks associated with security functions such as storage and monitoring can be delegated to non-veterinary personnel. It is recommended that protocols managing the receipt of controlled drugs into the practice are established and strictly adhered to, in order to facilitate reconciliation.
All controlled drugs not required for immediate use must be kept in a locked cupboard or compartment (‘safe’) that meets the specifications set out in section 28 of the Misuse of Drugs Regulations 1977, and which is of an ‘approved type’. ‘Immediate use’ means the amount of controlled drug that can be reasonably expected to be used throughout a working day. These drugs should still be closely monitored throughout the day. At the end of the working day, those controlled drugs available for immediate use must be locked up securely in their safe.
The safe must be constructed of metal, concrete or both. Where the safe is installed after 1977, it must be of an approved type. The safe must be fixed to the building or to the vehicle. When the key to the cupboard or compartment is not being used, it must be kept in a safe place. When the building or vehicle is unoccupied, the key must not be kept in it. The safe can be fitted with a combination lock of an approved type. Specifications for safes to store controlled drugs are noted in Appendix I at the end of this section.
Carrying controlled drugs in a vehicle
Veterinarians who carry controlled drugs in their vehicles for use at work must comply with the statutory 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. A locked vehicle boot, locked ute service box, locked cabinet within the service box or locked glove box currently meet these requirements.
If controlled drugs are kept in vehicles:
- only carry the smallest quantities of the drugs
- do not keep the key to the compartment in the vehicle when the vehicle is unattended
- lock the drugs in the cabinet if they are in the vehicle overnight
- try to park the vehicle in a locked garage or secure area overnight if controlled drugs are in the locked cabinet inside it, or consider removing the drugs if the parking area is not secure.
Having and using a controlled drugs register
VCNZ requires veterinarians to use a Controlled Drug Register to record the receipt, sales and stock levels and document reconciliations. This requirement is in place even though Section 41 of the Misuse of Drugs Regulations 1977 provides an exemption for veterinarians.
Veterinarians may use a manual register, an electronic register, or both. Veterinarians must be able to quickly and easily produce the controlled drugs register detailing the use of controlled drugs within their veterinary practice for examination and review. The register must be able to reconcile controlled drugs received, used and remaining on hand.
Reconciling physical stock of controlled drugs against sales and purchases
Physical stock of controlled drugs must be reconciled against sales and purchases. An important component of this process is the need to account for variances. Where a reconciliation identifies stock of controlled drugs that cannot be accounted for, the veterinarian must provide a reasonable and justifiable explanation. Discrepancies need to take into account multi-injection vials, leakage, loss by evaporation, product remaining in needle hubs and syringes, breakages and unused product remaining in a vial or bottle. The veterinarian must put in place strategies to deal with discrepancies, including those arising from recording issues and human error.
The minimum frequency for regular reconciliation of controlled drugs is monthly since it can be difficult to explain reconciliations easily and accurately if reconciliations are less frequent. At least two people should be responsible for the reconciliation process.
The veterinarian should resolve situations where the reconciliation does not balance. They should identify a reason where possible and take corrective actions to ensure that the reconciliation balances next time.
Where corrective action is taken to improve the accuracy of future reconciliations, yet unexplained variances continue, the veterinarian must report the variances to VCNZ. The veterinarian should seek advice from VCNZ if they cannot explain any large or recurring error in the reconciliation.
Strategies that may assist a veterinarian to comply with the above requirements include:
- ensure the receipt of the controlled drugs is accurately recorded
- develop good systems to ensure that all purchases and use are accurately tracked
- maintain a logbook that tracks purchases, and use full packs of controlled drugs to make reconciliation easier
- increase the frequency of reconciliations
- Reconcile more frequently any product that is used more frequently and any product in multi-injection vials
- consider reducing the number of controlled drugs used in the veterinary practice
- consider restricting access to controlled drugs to particular authorised staff members
- consider implementing a procedure that requires two people to be involved each time a
- controlled drug is removed from the safe for use.
Disposing of controlled drugs
The veterinary practice must dispose of expired, damaged, returned or unused controlled drugs in a way that destroys them so that they are non-recoverable and their consumption is impossible or improbable (so they cannot be abused or diverted for any other use). The Ministry of Health’s main concern is to prevent diversion. If access to a commercially available disposal system is not possible, the Ministry of Health considers the most appropriate disposal method (to prevent diversion) of controlled drugs is flushing them into the sewerage system. Even so, it recognises the potential harmful environmental consequences.
- take all steps to prevent diversion
- render controlled drugs inactive in the disposal process
- ensure any controlled drugs being disposed of away from the practice remains under the control of a veterinarian, or that the veterinarian is satisfied that suitable controls are in place to prevent diversion
The following disposal methods are suggested.
- Small amounts left in syringes, bottles or ampules are placed in a sealed, tamper-proof sharp container and the container is destroyed by a company specialising in destruction of bio-medical products.
- Tablets are crushed and ampules opened and then placed in a sharp container, the container is destroyed by a company specialising in the destruction of bio-medical products.
- Full or incomplete bottles (depending on volume) are either disposed of in a sharps container and destroyed by a company specialising in destruction of bio-medical products, or emptied into the sewerage system.
- Controlled drugs are delivered to a pharmacist who has agreed to accept them for disposal.
- The disposal of controlled drugs (if being carried out within the clinic) is witnessed by a veterinarian, nurse or veterinary technician. The clinic recording system for controlled drugs is appropriately updated to note this disposal, the amount, and the date. The disposal is signed (or recorded if noted in a computerised system) by the veterinarian disposing of the controlled drugs and by the witness.
Appendix 1: Summary of requirements for the custody of controlled drugs: Steel safes
Section 8 set outs how to use or authorise a registered veterinary medicine (restricted or unrestricted) off label, a human medicine or a preparation that has been compounded.
Actions that veterinarians should take when using or authorising off label:
- Comply with all of the points in sections 1 to 7 of the Veterinary Medicines sections of this Code.
- Consider if a registered veterinary medicine is available that will adequately achieve the intended effect and ensure the welfare of the animal. If appropriate, choose the registered veterinary medicine.
- Do not supply any consented or unconsented human medicine for use as a veterinary medicine, or any registered veterinary medicine off label unless the additional risks that might occur (such as residues) are manageable.
- Only import unconsented human medicines or veterinary medicines from overseas after obtaining Special Circumstances Approval from MPI.
- Ensure where possible, when considering combining different products, that the products are clinically compatible for concurrent use and that appropriate withholding period advice is provided to the person buying the product.
Understanding section 8
General requirements for using or authorising the off-label use of products
The VCNZ statement on Discretionary Use of Human and Veterinary Medicines by Veterinarians sets out VCNZ expectations for using or authorising these types of products.
Deciding which product to use
The process of deciding which product to use can be compared to a linear cascade (see below).
Use a registered veterinary medicine if it is available and can be used in compliance with the label and registration conditions (or an exempt veterinary medicine) to achieve the intended clinical effect.
If there is no such suitable product, use a registered or exempt veterinary medicine if available. The medicine must be expected, with discretionary (off-label) use, to meet the treatment and welfare needs of the animal(s) and manage the risks identified in the ACVM Act.
If no registered or exempt veterinary medicine is available which, even with discretionary use, meets the treatment and welfare needs of the animal(s), use a ‘human medicine’ or preparation specially compounded by or for a veterinarian. Only use this medicine if the risks identified in the ACVM Act can are still manageable.
If choices 1 to 3 are not available, and the animal’s need justifies it, veterinarians may apply to the MPI ACVM Group to import a veterinary medicine to ease an immediate welfare need of an animal under their care provided certain conditions are met. Contact the MPI ACVM Group for information.
Choosing a veterinary medicine
In all cases, a veterinarian’s decision for discretionary use must balance the potential negative effects of the drug with its benefits to the animal.
Veterinarians must have worked through each step before deciding which product to use. The cascade should not restrict a veterinarian’s choices; it should facilitate good decision-making by effectively managing the risks associated with the type of product used. Ultimately, the veterinarian can choose the type of product to use provided they can justify their decision.
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 using the medicine in these situations.
Off-label use of a registered veterinary medicine
Off-label use of a registered veterinary medicine occurs when the use does not comply with the approved claims (that is, the route of administration, dose rate, duration of treatment, target species or the condition being treated).
Not all RVMs are permitted to be used off label. In that situation, the medicine will have a condition of registration identifying the prohibition. Where an ‘over the counter’ product is permitted to be used off label, it will carry a condition of registration stating that before off-label use, the user 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.”
Proprietary label information
The product label includes all the information that MPI has approved as being able to be supplied to the person the product is sold to, irrespective of the form of that information. Proprietary label information therefore includes:
- the physical label attached to the product
- label information on product packaging
- additional loose material packed with the product.
Medsafe does not assess human medicines for use in animals
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.
A veterinarian should obtain the informed consent of their client when the risks associated with using a registered veterinary medicine off label, or using a human medicine, are not well known.
If a registered veterinary medicine is available and can be used to achieve the same intended effect within the label and registration conditions, a veterinarian should choose it before the use of a human medicine or the off label use of a restricted veterinary medicine, or a compounded preparation. In some situations an RVM may be available but may not be the preferred treatment choice. This is acceptable if the veterinarian can justify their choice case by case and if choosing a human medicine is the exception rather than the rule. The routine use of a PM, or compounded preparation, in place of an RVM should not be based solely on the cost.
Using unconsented medicines under section 29 of the Medicines Act 1981
To find out the consent status of a human medicine in New Zealand, go to Medsafe database search.
Veterinarians can use unconsented human medicines (section 29 medicines) legally to treat animals. However, the Medicines Act 1981 does not allow veterinarians to purchase these products from a supplier based in New Zealand. Veterinarians can only obtain unconsented medicines by importing them after obtaining Special Circumstances Approval from MPI. Veterinarians can import such medicines in quantities to treat a specific case but cannot hold any of that medicine in anticipation of future use.
Getting MPI approval to use “animal welfare medications”
In certain specific circumstances MPI will allow veterinarians to import and hold particular unconsented human medicines in anticipation of use. These medicines are referred to as ‘animal welfare medications’. Veterinarians need MPI approval to import and hold particular unconsented human medicines in anticipation of use.
The current list of ‘animal welfare medications’ for companion animals, as approved by MPI are in the Special Circumstances Approval ACVM Information Requirements.
Authorising more than one product for use in treating a food-producing animal
When authorising more than one product for concurrent use in treating a food-producing animal, veterinarians must ensure where possible that all products are clinically compatible for concurrent use and that appropriate withholding period advice is provided to the end user.
The veterinarian must consider the pharmacology and elimination of each product and their active ingredients, as well as each withholding period applied to the registered veterinary medicines. The veterinarian must assign a withholding period that allows for any interactions between concurrently administered products, changes in the elimination of the drugs, and any other impacts the concurrent use may have on the efficacy, safety, and residue elimination of the active ingredients.
The pharmacology and elimination of a product can change significantly depending on the species it is administered to, the dose, the administration route, and concurrent use of other products. In food-producing animals, the veterinarian authorising use in any way other than as stated on the product label, including the concurrent use of more than one product, is responsible for ensuring that the authorised use does not cause residues to exceed the maximum residue levels or maximum permissible levels for all medicines used by providing appropriate withholding period advice to end users. This requirement applies to all products for which maximum residue level apply under the Food Act and for which maximum permission levels apply under the Animal Products Act.
Deciding an appropriate withholding period
The withholding periods approved for a veterinary medicine are based on residue trial work on the use of that one product, in the approved species, and in line with the approved dose rate and interval. MPI has not evaluated use of the product in any other way. Also, the withholding period approved for the product does not apply.
In deciding what an appropriate withholding period is, veterinarians need to consider their own knowledge and experience as well as that of their colleagues. Veterinarians also need to consider technical advice (from a number of possible sources), peer and non-peer reviewed publications, available current data, and the MPI default withholding periods.
Section 9 sets out how to use or authorise a compounded veterinary preparation (CVP) for animals under their care.
Actions veterinarians must take when using or authorising a compounded veterinary preparation:
- Comply with all the points in sections 1 to 7 of the Veterinary Medicines sections of this Code.
- In situations where there is no veterinary medicine approved for the treatment of the condition (i.e. there is no on label indication and dose rate), consider whether there is:
- an approved veterinary medicine which would be appropriate to use off label to achieve the same therapeutic effect, or
- if there is an appropriate consented human medicine that will achieve the same therapeutic effect. If any such trade-name product is available and will adequately achieve the intended effect and ensure the welfare of the animal, the veterinary must choose this product in preference to a CVP.
- Consider whether an unconsented human medicine or overseas registered veterinary medicine is available that could be imported using MPI’s Special Circumstances Approval form within an acceptable timeframe. If appropriate, use this medicine in preference to a CVP.
- Ensure that CVPs do not contain prohibited or restricted substances as defined by MPI.
- Ensure that the CVP is compounded, sold and used for the treatment of an animal under the compounding veterinarian’s direct care in accordance with ACVM regulations.
- Be competent in all aspects of formulation and compounding in situations where the CVP is compounded personally. Be responsible for the product, including its preparation, packaging, shelf life, labelling, and any workplace safety concerns.
- Be satisfied that any third party contracted to do the compounding is competent. Issue the third party with a compounding order specifying the ingredients, quantity, packaging, shelf life and labelling. The veterinarian requesting the compounding is responsible for all aspects of compounding even when it is carried out by a third party.
- Ensure that a documented system for compounding is in place.
- Compound only enough CVP to manage short-term requirements. Do not store the preparation in anticipation of future needs.
- Do not advertise or promote CVPs as veterinary medicine trade-name products or display them for sale to the general public.
- Do not import CVPs without approval from MPI.
Understanding section 9
MPI 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 CVPs have not undergone the usual regulatory assessment, and so expose the veterinarian, the animal(s) treated, the people involved with treatment and the public interest to potential risks. For more information, see the VCNZ Statement on Compounding Veterinary Medicines and MPI Guidelines on Developing a Documented System for Compounded Veterinary Preparations.
Veterinarians may compound a CVP under entry 9 in schedule 2 of the Agricultural Compounds and Veterinary Medicines (Exemption) Regulations 2011. A veterinarian who chooses to compound a CVP must follow the ACVM requirements in Regulations 7, 10, 12 and 14 and the CVP Notice. The veterinarian must clearly understand and comply with those expectations. For more information, see the VCNZ Statement Manufacturing Veterinary Medicines.
Compounding a CVP should be seen as a last resort and only undertaken because a trade name product in the desired form or presentation is otherwise unavailable for animal treatment. The guiding principle should be that the CVP improves the animal(s) welfare over and above anything else that is currently available and is therefore a more appropriate veterinary medicine to use.
When deciding what treatment to use, veterinarians should consider the following choices in order. The primary choice is to use an RVM in compliance with the label and registration conditions to achieve the intended clinical effect. If no such RVM is available, the second choice is to use an RVM off label. The third choice is to use a human medicine. The fourth choice is to use a CVP.
Veterinarians should only compound sufficient material to satisfy their clinical requirements, and not in anticipation of future needs. The preparation should only be compounded for a particular animal. However, situations do occur where a group of animals require treatment.
Veterinarians who supply a CVP to a client must include as labelling information:
- name or description of the product
- name and contact details of the manufacturer or the veterinarian who made the product
- active ingredients
- directions for use
- use by date/expiry date, if applicable
- precautions, if any, for use
- batch number (or equivalent).
Section 10 sets out the actions of veterinarians when decanting. Decanting is a form of compounding that involves breaking down trade-name products into more convenient pack sizes.
Actions veterinarians must take to when decanting or breaking down a trade-name product:
- Ensure that the product is not altered in any way, except when changing the original packaging and labelling.
- Ensure that no additional hazards are introduced through careless or inappropriate procedures during decanting or breaking down.
- Ensure that the choice of alternative packaging does not jeopardise the quality of the product.
- Ensure that all crucial information about the product is provided to the client, including the veterinarian’s contact information and additional instructions.
Understanding section 10
At times, a client may not be able to use the entire 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.
If the veterinarian breaches the integrity of the trade name product as set out above, they are responsible for any adverse consequences.
Section 11 sets out the actions of veterinarians who routinely fill veterinary authorisations in their practice issued by veterinarians from outside their practice.
Actions veterinarians must take to provide a dispensing service.
- Have an Operating Plan for Restricted Veterinary Medicines Sellers that MPI has approved.
- Contact the external authorising veterinarian if the authenticity or validity of the authorisation is in doubt.
- Prepare the order as set out in the written instructions from the authorising veterinarian.
- Contact the authorising veterinarian if the written authorisation needs changing, to discuss the changes and obtain a new authorisation issued (if the requested changes are accepted).
- Keep a record of the transaction with a copy of the authorisation.
Understanding section 11
Some veterinarians may wish to operate an RVM dispensing service (a veterinary pharmacy) to fill authorisations from other veterinarians not in the same practice or from other people recognised by MPI to authorise the purchase and use of RVMs in line with the approved operation plans. To dispense this way, the veterinarian must have an operating plan approved by MPI that governs the sale of RVM. Veterinarians should contact MPI for guidance on developing their own operating plans.
The accepted standard of practice for providing this dispensing service is set out in the MPI document Operating Plans for Restricted Veterinary Medicine Sellers.
Veterinarians who are not approved RVM sellers may fill a one-off urgent authorisation. Two occasions are when a client has gone on holiday and forgotten to take their animal’s treatment, or when another practice has run out of a medicine over a weekend or holiday period.
Section 12 sets out actions veterinarians must take when using a generic chemical.
- Recognise that the generic chemical has received no regulatory control as to its quality and fitness for purpose for treating animals.
- Address risk management of the generic chemical in an adequate manner.
- Advise the client about the use of the generic chemical, including adequate risk management advice as appropriate.
- Ensure the client has received appropriate withholding period advice about residues resulting from using the generic chemical, as applicable.
Understanding section 12
See the glossary definition of generic chemical. Some generic chemicals are methylene blue, zinc oxide, and magnesium sulphate. Chemicals with active ingredients that would prompt the need for registration (such as zinc bacitracin and chloramphenicol) are excluded.
Section 13 covers the prohibited use of veterinary medicines or veterinary PM on or by people.
Veterinarians must not use, recommend or authorise the use of veterinary medicines, PM, pharmacy-only medicines or restricted medicines (as defined in the Medicines Act 1981) for use on or by people.
Understanding section 13
The Medicines Act 1981 contains a specific exemption that allows veterinarians to authorise the sale, supply or administration of prescription medicines (as defined in the Medicines Act 1981) to treat animals under their care. 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 PM to treat people.
Section 14 is about the advertisement or promotion of RVMs to end users (including offering purchasing incentives).
When advertising RVMs veterinarians must
- State that the product is only available under veterinary authorisation
- Only advertise RVMs if doing so is unlikely to jeopardise the risk management role of the authorising veterinarian.
- Not advertise antibiotics to the public.
- Not advertise or offer purchase incentives for products with a specific condition of registration that prohibits them being advertised.
- Only display a registered veterinary product (and its label) where the public can see it if doing so does not influence a person’s decision to buy it.
Understanding section 14
Veterinarians may advertise RVMs to end users (including offering purchasing incentives) provided there is no specific condition of registration prohibiting this, and the product is not an antibiotic.
The MPI document Advertising guidelines for products registered under the ACVM Act sets out MPI expectations under the Animal Compounds and Veterinary Medicines Act 1997 about the standards veterinarians must maintain when advertising and promoting veterinary medicines. Veterinarians are expected to know and comply with the requirements set out in those guidelines.
The advertising veterinarian must tell the potential buyer to discuss treatment options for their animal or animals with their veterinarian.