Veterinary Medicines

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

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

  3. When using or authorising restricted veterinary medicines, veterinarians must comply with the requirements and expectations of MPI ACVM Group in relation to authorisation. This is set out in their published ACVM Notice Requirements for Authorising Veterinarians 28 August 2015 (www.foodsafety.govt.nz/elibrary/industry/Veterinarians_Recognised-Sets_Expectations.pdf)
    Additionally veterinarians must:
    1. Comply with all of the points in paragraph 2 above;
    2. Obtain sufficient information to assist risk assessment and to support the choice of that veterinary medicine through either:
      1. Veterinary consultation as defined in the glossary, or
      2. Issuing Veterinary Operating Instructions as detailed in paragraph 4
    3. Create and maintain appropriate records detailing the decision and the action taken; and
    4. Honour requests for written authorisations in lieu of dispensing.
     

  4. When issuing Veterinary Operating Instructions (VOI), veterinarians must comply with the requirements and expectations of MPI ACVM Group in relation to VOI. These are set out in MPI's Guidance Document Veterinary Operating Instructions 28 August 2015 (www.foodsafety.govt.nz/elibrary/industry/Veterinary_Operating-Guidelines_Issuing.pdf).
     
    Additionally veterinarians must:
    1. Tightly define the specific treatment circumstances in which each restricted veterinary medicine is authorised to be used under VOI.
    2. Authorise use of restricted veterinary medicines under VOI only in circumstances where there is no reasonable expectation that either veterinary judgement or a veterinary diagnosis would be needed to ensure that the use of the product in the specific case is appropriate and justified.
    3. Not use VOI to authorise the use of any controlled drug as defined in the Misuse of Drugs Act 1975;
    4. Be able to provide evidence that the process for developing and issuing VOI has been followed appropriately prior to implementation of the instructions;
    5. Be able to provide evidence that they have identified:
      1. The specific competencies required of personnel authorised in the VOI;
      2. Appropriate detail on the training and assessment of the personnel in relation to those competencies
    6. Make it a requirement of the VOI that specific records are kept in relation to every instance of use of the restricted veterinary medicines by VOI specified personnel. Records must document sufficient information to permit easy assessment of compliance with the terms of the VOI;
    7. Be able to provide evidence of sufficient monitoring that allows the veterinarian to be confident that the terms of the VOI are being complied with;
    8. Review the competency of the personnel at least annually by personally assessing the use of the restricted veterinary medicines by the user;
    9. Withdraw the VOI immediately in situations of non compliance.
     

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

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

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

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

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

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

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

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

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

Flowchart of Veterinary Medicine Supply
 

(Click on image for larger version)