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.
Section 1: Product Stewardship
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
Section 2: Legislative requirements
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
Section 3: Authorisation
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
Section 4: Veterinary Operating Instructions
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
Section 5: Documentation
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
Section 6: Antibiotic use
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
Section 7: Controlled drugs
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
Section 8: Off label use
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
Section 9: Compounded veterinary preparations
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
Section 10: Decanting
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
Section 11: Providing a dispensing service
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
Section 12: Using a generic chemical
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
Section 13: Use of veterinary medicines or prescription medicines by people
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
Section 14: Advertising
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