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FAQ from 2009 Workshops for Vets(NZFSA specific)

July 2009

Approval of operating plans

Why did NZFSA approve the use of leptospirosis vaccines under an approved operating plan?

AsureQuality lodged a submission with NZFSA to approve an operating plan that would provide vaccination programmes for dairy farmers using registered leptospirosis vaccines. The operating plan provides for the authorisation of leptospirosis vaccines for sale and use. This plan removes the need for veterinary authorisation.

The approved operating plan for leptospirosis vaccines is limited to routine herd vaccination, which does not require any veterinary involvement in diagnosis, product choice, adjustment of the vaccination programme or management of adverse events.

NZFSA is satisfied that the registered products’ safety records do not pose a threat to animal welfare, and the likelihood of adverse events for the specified use is minimal. The operating plan details how the vaccination programmes will be managed and how the vaccine will be distributed with sufficient security to ensure the products would not be diverted for other uses.

AsureQuality has significant experience in the area of tuberculosis testing and NZFSA is satisfied that all the administrative tasks associated with programming routine work, and ensuring work is completed in a timely manner, will be managed appropriately.

Is the Ministry of Health or Department of Labour concerned about other factors of routine vaccination programmes such as shed hygiene?

In discussions with the Department of Labour and the Ministry of Health the only concerns that were raised related to the administration of leptospirosis vaccines. However, NZFSA acknowledges that both parties would have a vested interest in any aspect of routine vaccination programmes, such as shed hygiene, that could have a positive or negative impact on the prevalence of leptospirosis in the work place. Nevertheless, NZFSA does not consider that aspects such as shed hygiene would alter the choice of vaccine for routine vaccination of dairy cattle to the extent that veterinary authorisation is essential.

What criteria does NZFSA use to assess an operating plan?

NZFSA uses a robust set of criteria to assess operating plans involving restricted veterinary medicines where veterinary authorisation is the primary form of authorisation.

1. The plan must be managed by a single party that can impose and maintain control over the authorisation, purchase, distribution, dispensing, and use of the specified veterinary medicines.

2. The detail of the plan must be in accordance with the principles of a quality system and any particular specification imposed by NZFSA.

3. The plan must specify the means of authorisation of sale and use that will be used in lieu of veterinary authorisation for restricted veterinary medicines.

4. The veterinary medicines must be specified.

5. The uses of the veterinary medicines must be specified and limited to those which, in NZFSA’s opinion, do not require expert veterinary judgement, oversight and advice because the plan provides such detailed use specifications.

6. There must be acceptance that NZFSA can and will monitor compliance with the operating plan as it sees fit.

Won’t NZFSA be inundated with requests for a large number of products to be used under approved operating plans?

While there may be a large number of requests, the criteria used to determine if a product can be used under an approved operating plan are very stringent. Operating plans that do not meet the specified criteria will not be approved.

What is the role of AsureQuality?

AsureQuality administers the approved operating plan that allows the authorisation of the sale, purchase and use of specified leptospirosis vaccines for the purpose of routine vaccination of dairy cattle.

Reassessment of products

Will reclassification, for example the removal of the veterinary authorisation requirement for some products, result in more adverse events such as reactions from local anaesthetics?

The potential for adverse events will be considered in the review that will be undertaken before any reclassification of products occurs.

Removal of the veterinary authorisation requirements will not occur in cases where it is clear that veterinary authorisation is the only practical way of managing the risks down to an acceptable level, or in circumstances where other rules of classification still point to veterinary authorisation as the only practical management tool.

What are the reassessment criteria for the reclassification of veterinary medicines?

The criteria set out in section 29 of the ACVM Act are:

• there must be significant new information on a matter related to the use of the product, or

• there must be significant changes in the use of the product.

What is the process for determining if a product needs to be reassessed?

Anyone can bring information to the attention of NZFSA and request a product, or group of products, be reassessed (and possibly reclassified). NZFSA will acknowledge the request and if it appears that the information supporting the request meets the criteria for reassessment, then it will follow the reassessment procedure specified in section 29 of the ACVM Act.

Each reassessment is primarily influenced by the strength of the risk management argument presented in support of change or the status quo. However, the outcome can be influenced by practicality and the statutory obligation to impose regulatory intervention in a manner that results in acceptable risk management, at the least cost, to New Zealand as a whole.

Who decides if a product needs to be reassessed?

If the Minister for Food Safety directs NZFSA to reassess a product, then NZFSA must do so (ref section 38 ACVM Act).

All other requests for a product, or group of products, to be reassessed will be considered on a case by case basis by NZFSA. Reassessment will not be initiated if the specified criteria are not met.

Are reassessments applied to specific products or groups of products?

Reassessments are applied to specific products, or groups of products, that have the same active ingredients and similar formulations. However, the review prior to reassessment is not limited in that way and could involve a more generic group of products. This was done with antibiotics in 2001 when new information concerning antibiotic resistance was considered. In a generic review, if the outcome supports change, then the product, or group of products, would still need to meet the criteria specified in section 29 of the ACVM Act.

Who is authorised to reclassify a product?

To reclassify a product, the conditions of registration of that product have to be amended accordingly. This is done by managers in the Approvals and ACVM Group, under delegated power authorised by the Director-General of NZFSA, as a variation in registration.

What is the consultation process for veterinary medicines that are reassessed and reclassified?

All reassessments must be processed as if they were new registrations. This requires them to be publicly notified in the NZ Gazette, giving every person the opportunity to comment on the reassessment. All comments received must be considered as part of the reassessment. Where a reassessment is likely to have significant implications, NZFSA will notify key industry groups.

When assessing a product, does NZFSA take information about similar products into account?

Yes, there is a statutory obligation to use all relevant and pertinent information (that is not under data protection) available to NZFSA when making a decision on any application.

Is there a timeframe for these reassessments?

Apart from the reassessment of antibiotic combinations containing aminoclycosides, which should be completed by the end of 2009, no other reassessments are scheduled in the short term.

Who is driving the reassessment of hormonal growth promotants and what is the likely outcome?

Hormonal growth promotants (HGPs) were identified as a possible product group for reassessment because of the potential for these products to be managed under an approved operating plan. However, no party has asked NZFSA to review the current arrangements, so at this stage no such reassessment is planned.

Proposed names/terminology

Why does the term ‘prescription animal remedy’ need to change?

The proposed changes to the term ‘prescription animal remedy’ (PAR) and the PAR classification system have been prompted by changes in terminology used in the ACVM Act, which make the terminology used in the Animal Remedies Act 1967 obsolete. The terms ‘prescription’ and ‘animal remedy’ are not used in the ACVM Act. Also, the term ‘prescription animal remedy’ no longer reflects the nature or range of products available in New Zealand, or the actual conditions of registration.

NZFSA is confident that the new term ‘restricted veterinary medicine’ meets the requirements of the ACVM Act and more accurately reflects the fact that some kind of authorisation is required for veterinary medicines with restrictions on their sale and use.

Why does the existing PAR sub-classification system need to change?

Some of the changes in how veterinary medicines are managed, such as products used for biosecurity purposes, are not adequately provided for in the existing PAR sub-classification system, and the conditions on products are often misrepresented. The new sub-classification system aims to better manage the diverse range of veterinary medicines now available in New Zealand.

The terms Class I and Class II are no more descriptive than the proposed Class A. Has NZFSA considered alternative suggestions?

Yes. NZFSA has considered alternative suggestions such as RVM 1, 2, and 3, and mid-alphabet letters. At this stage Classes A, B and C are the preferred options, but NZFSA is still considering the terms to be used. (Note that since the workshops it has been proposed to use the term ‘restricted veterinary medicine’ only, ie without further distinctions such as 1, 2, 3 or A, B, C. This proposal has gone to AVMAC for discussion and a decision should be announced in August.)

Won’t the sub-classification ‘Class A’ be confused with Class A drugs?

NZFSA and the Veterinary Council of New Zealand (VCNZ) are confident that the proposed A, B, and C sub-classification system will not be confused with Class A controlled substances under the Misuse of Drugs Act, especially as there are no Class A controlled substances routinely used as veterinary medicines. (Note that since the workshops it has been proposed to use the term ‘restricted veterinary medicine’ only, ie without further distinctions such as 1, 2, 3 or A, B, C. This proposal has gone to AVMAC for discussion and a decision should be announced in August.)

Will the term ‘restricted veterinary medicine’ be abbreviated?

NZFSA expects that, for convenience and when there are label space limitations, the term ‘restricted veterinary medicine’ is likely to be abbreviated just as prescription animal remedy was abbreviated to PAR. RVM is very likely to be the preferred abbreviation. However, the actual abbreviation is likely to be influenced by the labelling preference of registrants of restricted veterinary medicines. NZFSA has no strong opinion on what the abbreviation should be, but it must give effect to the concept of ‘restricted’ with no reference to prescription.

Will the changes mean that farmers gain easy access to drugs such as Xylazine and local anaesthetics?

No. The same restrictions will apply to ensure responsible sale and use of restricted veterinary medicines.

Can a veterinary medicine have two classifications?

No. Each product will have only one classification.

Will PAR Class I and PAR Class II veterinary medicines have the same conditions?

It is proposed to reclassify all current PAR Class I and PAR Class II veterinary medicines as ‘restricted veterinary medicine Class A’. They will have the same condition to make it clear that sale and use will be subject to veterinary authorisation. Any additional restrictions specifying requirements for storage, handling or extra records will be product specific. (Note that since the workshops it has been proposed to use the term ‘restricted veterinary medicine’ only, ie without further distinctions such as 1, 2, 3 or A, B, C. This proposal has gone to AVMAC for discussion and a decision should be announced in August.)

Label changes

Why is there such a long transition period? Won’t this cause confusion?

Changing labels is very expensive. NZFSA does not anticipate that the proposed transition period will cause any confusion. In the unlikely event that old terminology causes significant confusion for a particular product, that specific case will be addressed rather than imposing costs on all product registrants.

Registrants have advised NZFSA that a few products on the New Zealand market have not changed in 10 years, and are not likely to change in the near future. This is likely to mean that a very small number of products may still have the old PAR terminology beyond 2012 (beyond the normal registration renewal period of 3 years). All other products are likely to adopt the new terminology within the next 3 to 5 years simply because the registrants are changing other aspects of their labels.

NZFSA will ensure veterinarians and approved traders are fully aware of the implications of each product’s restricted status.

Would it not be easier if overlabels were placed over the old terminology on product labels?

There is still a significant cost attached to using overlabels. Having the old terminology synonymous with the new terminology for a period of time does not pose a significant risk, so the additional expense cannot be justified. There is no obvious gain to be achieved by forcing the change to occur quickly.

Drug classification

Why are some drugs, such as Opioids and Butorphenol, not classified as PAR Class IIIs?

To the best of NZFSA’s knowledge, there are currently no active ingredient veterinary medicines used in New Zealand that require administration by a veterinarian to manage the risk areas specified in the ACVM Act.

Potential harm to humans and diversion of the products for use in humans are not ACVM Act risks. They are Hazardous Substances and New Organisms Act risks (or Misuse of Drugs Act risks in cases involving controlled substances).

Why is Omeprazole restricted as a human medicine but not as a veterinary medicine?

Human medicines are managed under the Medicines Act 1981, which is administered by Medsafe (part of the Ministry of Health). Medsafe has a standing policy to make a new active ingredient restricted and will not change its status until:

• the active has been marketed for at least three years in New Zealand

• it is commonly used during those three years

• there are no significant adverse events during that time, and

• it is in an appropriate formulation for OTC.

NZFSA has been advised that Medsafe has been asked to reconsider its classification of Omeprazole.

Under the ACVM Act, Omeprazole is recognised as a safe active ingredient that is not likely to cause pain or distress in a treated animal. Precise diagnosis is not essential to recommend its use or to avoid pain or distress in animals.

The formulation of veterinary medicines that contain Omeprazine are not conducive for human use so it is unlikely that they would be used in this way, and Medsafe was comfortable that it would not be diverted to human use.

Is Fentanyl listed in the MODA schedules?

Yes. Fentanyl is listed in Schedule 2 as a Class B category 3 controlled substance in MODA. Veterinarians must comply with the requirements of MODA accordingly.

Why aren’t tighter restrictions placed on products such as Spot On that are known to have potential harmful side effects?

The risks associated with Spot On were assessed when the product was registered and they were addressed adequately in the label information.

While NZFSA receives an occasional adverse event report, there has been insufficient information on the actual cause of the adverse event to support a change in classification. If veterinarians regularly see adverse events involving products, they should report them to the registrants who have an obligation to advise NZFSA.

Why have some PAR III products been reclassified without any consultation?

The registration of each of the products concerned was altered as part of the routine renewal of registration. They were not subject to reassessment. NZFSA consulted Medsafe and it was confirmed that the Ministry of Health did not require the products concerned to be classified PAR III. There was no longer any justification for these products to have more stringent classification.

Prior to the action being taken, NZFSA advised the Agricultural Compounds and Veterinary Medicines Advisory Council (AVMAC) and the New Zealand Veterinary Association (NZVA) of the intention to classify these products as PAR II, and the decision was publicly announced in our newsletter AgVetLink. At the time, NZFSA received no objections to this decision.

Is NZFSA planning to do more consultation in regard to the reclassification of veterinary medicines?

For the most part, the same rules for classification that have been applied to veterinary medicines for the last 10 years are being applied to each new registration. NZFSA consults stakeholders when the rules are being changed. It does not proactively seek views on each individual application or when the rules are applied as normal.

Has classification been discussed with APVMA?

Yes. APVMA has been consulted and their views have been taken into consideration.

Why are animal feeds classified as veterinary medicines?

Animal feeds meet the definition of a veterinary medicine under the provisions of the ACVM Act because they are intended to manage animal nutrition. However, NZFSA acknowledges that they are clearly not medicines in the common use of the term. NZFSA considers animal feeds to be ‘oral nutritional compounds’ and does not refer to them as veterinary medicines.

Why is the default classification over-the-counter (OTC) rather than restricted?

The decision to register and impose conditions under the ACVM Act is based on the long-standing government policy of no more regulatory intervention than is necessary to achieve the purpose. NZFSA must consider the costs incurred as a result of imposing conditions, and impose them only if they are needed to manage the risks down to an acceptable level (ref section 21(1)(d)). This means that OTC is basically the starting point.

Are veterinarians responsible for providing advice on OTCs? Doesn’t this effectively make them PARs?

Anyone can sell and use OTC products. The condition of registration related to advertising and promotion makes every seller responsible for representing products in a manner that is consistent with their registration.

From NZFSA’s perspective, the same obligations apply to veterinarians and any other party selling OTC products for approved uses.

What are the requirements for keeping reconciliations for PAR IIs?

The requirements are currently specified in the ACVM Standard for Prescription Animal Remedy Veterinary Medicines. These will change when the new classification system comes into force. NZFSA will require a sufficient amount of reconciliation to give veterinarians confidence that the products are being used as expected. At the same time veterinarians may have obligations under the HSNO Act and MODA that they must comply with.

Authorisation

How is ‘authorisation’ defined?

An authorisation is an instruction, in an appropriate documented form, from the appropriate person/organisation authorising:

• the use of a restricted veterinary medicine by the specified person in accordance with the authorisation

• the holding of a relevant restricted veterinary medicine in accordance with the authorisation

• the sale from a person recognised to sell restricted veterinary medicines to a person specified in the authorisation.

The definition when specifically applied to a veterinarian is an instruction, in an appropriate documented form, from a veterinarian authorising:

• the use of a restricted veterinary medicine by the specified person in accordance with the authorising veterinarian’s instructions

• the holding of a relevant restricted veterinary medicine by a person who is neither a recognised trader nor a veterinarian

• the sale by a person recognised to sell restricted veterinary medicines to a person specified in the authorisation.

The definition includes in-clinic records of the veterinarian’s decisions to use restricted veterinary medicines.

Loss of recognition status

Can loss of recognition of a veterinarian be initiated by both NZFSA and VCNZ?

Recognition of a veterinarian is granted by NZFSA and it can be removed only by NZFSA.

NZFSA will investigate and review the actions of a veterinarian in regard to compliance with the performance and technical standards for recognition. VCNZ will investigate the actions of a veterinarian in regard to compliance with the Code of Professional Conduct. In both cases the outcome could prompt NZFSA to revoke the recognition.

If a veterinarian refuses to issue a veterinary authorisation will he/she lose recognition?

There is no statutory obligation under the ACVM Act that requires a veterinarian to issue a veterinary authorisation. Therefore, choosing not to issue a veterinary authorisation is not grounds for revoking recognition.

Role of Approvals and ACVM Group

Is the Approvals and ACVM Group concerned about efficacy?

Yes. The Group is very interested in the efficacy of products. NZFSA requires considerable efficacy data to support a registration where inefficacy may result in unnecessary or unreasonable pain or distress in animals.

When classifying a veterinary medicine, why is the Group concerned about risks to trade or market access?

Apart from the ACVM Act statutory obligation on NZFSA to do so, NZFSA has mutual recognition agreements in place with overseas governments.

Under these agreements, there is an expectation that NZFSA, on behalf of the New Zealand Government, will manage the use of veterinary medicines in a way that protects the reputation of New Zealand as a source of safe and suitable food.

Is NZFSA allowed to advocate the use of particular products?

NZFSA is the government agency responsible for administering the ACVM Act. As such, NZFSA cannot advocate the use of any product, or group of products, or any particular animal management system. NZFSA does have a role to play in ensuring affected parties understand their statutory obligations.

Why isn’t animal welfare a criterion for deciding the classification of veterinary medicines?

All the ACVM risks areas, including animal welfare, are considered when registering a product. The rules of classification do not list these risk areas separately because they are inherent matters when the rules are applied. For example, if a product is restricted because veterinary expertise is needed, the most likely reason that the expertise is needed is to protect the welfare of the animal to be treated.

What checks are in place to ensure a product isn’t making false claims?

It is NZFSA’s responsibility to ensure all registered products meet the requirements of the ACVM Act. When registering a veterinary medicine the applicant is required to supply:

• a draft product label

• a product data sheet

• supporting chemical and manufacturing data

• residue, efficacy and target animal safety data, and

• proof that the manufacturer is operating in compliance with good manufacturing practice (GMP).

For exempt products NZFSA investigates any suspicion or allegation of non-compliance.

What should veterinarians do if they think a product is incorrectly classified because of a high number of adverse reactions?

Veterinarians can choose which products to recommend. If veterinarians are concerned about the safety of a product, then they can choose not to recommend it. Veterinarians should notify product registrants of adverse events.

When an adverse event report is received, the product registrant must notify the Approvals and ACVM Group. The Group can only prompt changes in conditions of registration when there is sufficient evidence to support the change.

Traders

Can a trader change a prescription, eg the dose rate, or dispense another drug?

No, not without obtaining a direction to do so by the original authorising veterinarian.

If a trader dispenses a different drug, gives different advice, or has not stored the product according to the manufacturer’s instruction and the product becomes defective or ineffective, who is responsible if something goes wrong?

The trader is responsible.

Isn’t there a significant risk attached to allowing traders who don’t have formal training to dispense or give advice about veterinary medicines?

At the time, NZFSA did not consider that the ACVM risks would be significantly increased as a result of implementing the approved trader programme. All of the audits to date of approved traders (who are not veterinarians) have confirmed that they are all doing a satisfactory job and no adverse events have been noted.

Have you carried out checks on traders’ activities?

Every non-vet trader has had an entry audit. Those that are still trading have been audited again within the last three years. Most veterinary medicine wholesalers have already been audited or will be audited later this year.

Isn’t auditing traders a bit retrospective? Why wait until something goes wrong?

Auditing is an exercise in confirming that things are being done properly. Auditing ensures traders are operating as expected and determines if there are any weakness in the system before anything has the potential to go wrong. In addition to the audit process, all adverse events are investigated fully.

Is there a requirement for a trader to advise the prescribing veterinarian that a prescription has been filled?

No. There is no requirement for the trader to notify the prescribing veterinarian that the prescription has been filled.

If a client rings their veterinarian to advise them that they think there has been an adverse event associated with a product that the veterinarian prescribed, but it was dispensed by an approved trader, what should the veterinarian do?

The veterinarian should try to gain as much detail as possible to determine what the problem was, and establish if the problem was with the authorisation or the product. The veterinarian should report the event to the registrant of the product and/or NZFSA as an adverse event so that it can be investigated.

Codes of practice

What will happen to codes of practice?

All approvals for codes of practice (now deemed to be operating plans as a result of the 2007 amendment to the ACVM Act) that were in effect when the ACVM Act was amended will terminate in October 2010.

From October 2010, codes of practice that follow the operating plan model (ie they are organisation-specific) can be reinstated as approved operating plans. However, codes of practice that provide generic advice or guidance will not be re-instated as approved operating plans. NZFSA is currently discussing the fate of these codes with their respective owners.

Will the research, teaching and testing organisation (RTTO) codes of practice have to be rewritten?

There are currently three approved codes of practice that relate to the use of prescription animal remedies without veterinary authorisation. The ones owned by Massey University and Schering Plough Animal Health Ltd fit the operating plan model. They could continue in their present form after October 2010 if their owners wish.

The Royal Society’s code of practice is generic guidance and does not fit the operating plan model. It will not be approved by NZFSA after October 2010. The Royal Society will have to decide what it wants to do. It is anticipated, but not certain, that the Royal Society will want to maintain the code of practice as guidance to research, teaching and testing organisations.

NZFSA is working through the details of a programme to recognise RTTOs and expect each one to have its own operating plan, most likely following the Royal Society’s guidelines.

Will RTTOs be able to administer Class B products?

Currently, there are no Class B products that are classified in a way that restricts administration to only veterinarians. If in the future there is a Class B product that requires administration by a veterinarian, RTTOs will need to arrange for a veterinarian to administer the product. (Note that since the workshops it has been proposed to use the term ‘restricted veterinary medicine’ only, ie without further distinctions such as 1, 2, 3 or A, B, C. This proposal has gone to AVMAC for discussion and a decision should be announced in August.)