Code of practice for the use of prescription animal remedies (Schedule 4 substances) in the pig industry
Ratification Date: 24 Jul 2014
The role of the veterinarian in the pig industry ranges from herd health management to individual care. There has been an increase in intensification in the pig industry over the past 50 years or so, but recent community and scientific concerns about animal welfare may lead to less intensification in the future.
Legal and ethical constraints apply to the supply and use of PARs in the pig industry, regardless of the system of management.
The PARs drug supply chain that exists between manufacturer and end user includes wholesalers, feed mills, pharmacists and veterinarians.
The wholesaler may purchase PARs directly from a manufacturer and subsequently supply to a veterinarian; a pharmacist; another licensed, authorised or permitted wholesaler; or to an authorised receiver as outlined in the state’s Poisons Act (or equivalent) and Regulations. Authorised receivers, granted a license or permit by the relevant health department, include government departments, universities and hospitals, overseas countries and interstate distributors.
In all states except South Australia, a wholesaler may not supply PARs directly to an end user and cannot be authorised to do so by a veterinarian. Thus, in all states except South Australia, a licensed or authorised wholesale dealer is not permitted to dispense a prescription under any pretext. In some states (including Queensland), under exceptional circumstances, direct supply to an end user can be authorised by the Director General of Health.
In South Australia, registered wholesalers may supply to an end user directly, but only on the authorisation of a veterinarian responsible for, and with knowledge of, the end user’s pig herd. Authorisation in such cases can be given by telephone, but must be followed by written confirmation within three days.
The feed miller can supply feedstuffs containing PARs under specified conditions. Feed mills do not usually conform with the definition of a wholesaler, but may be licensed or authorised by a state’s Poisons Act (or equivalent) and Regulations as wholesalers able to supply PARs as stock medicines, to a veterinarian, pharmacist or another wholesaler under certain conditions, as outlined below, e.g. feedstuffs containing therapeutic substances at exempt or Schedule 6 levels (S6, for unrestricted sale; this may include substances that would be S4 if incorporated into feed at higher concentrations) or at S4 level (prescription only). The conditions of supply of restricted substances at S4 level to an end user specify that such supply must only be in a feedstuff and must be on, and in accordance with, the full written instructions of a veterinary surgeon and on his/her behalf, to the holder of such an order from a veterinarian.
The authorisation or licensing of a feed mill under the Poisons Act (or equivalent) and Regulations does not permit that feed mill to supply PARs for open retail sale with or without veterinary authority. Thus, feed mills may not, under any circumstances, supply S4 medicines to the public other than when incorporated in feed and then only after a veterinary prescription has been issued by the veterinarian (and copied to the food mill).
Where a person who mixes his/her own feed requires PARs for his/her herd, it must be acquired from a veterinary surgeon, a pharmacist (on a veterinary prescription) or from a feed mill as a feed concentrate (in accordance with full written instructions from a veterinarian). The concentrate may contain a therapeutic substance at such a level that it can be further mixed to produce medicated feed containing that drug at a specified lower therapeutic level.
There is no restriction on the supply of premixes or concentrates at levels not exceeding those set out in Schedule 6. Such premixes may be in the form of registered stock medicines or made to order by a feed mill.
The end user (the farmer) must be made aware of all medications that are in their feeds, including those used at sub-therapeutic levels. This is especially important for those farmers certified under APIQ (quality assurance program administered by Australian Pork Limited).
The pharmacist may dispense PARs to an end user for their animals, but only on veterinary prescription, with one exception: in Western Australia, a pharmacist may supply certain PARs in limited quantity (as specified in Regulation 39 Appendix H of the Western Australian Poisons Act) without a prescription in an emergency under certain specific conditions.
Emergency supply of PARs by a pharmacist is permitted in all states on the oral order of a veterinary surgeon, who must forward written confirmation by prescription within 24 hours.
The veterinarian accepts professional responsibility for the supply and use of PARs in the animals under their care. Veterinarians can possess PARs only for the lawful practice of their profession. They are not permitted to merchandise them — that is, they cannot sell them without proper professional involvement in their use and can only supply them when they have made a diagnosis or have planned a medication program.
Legal obligations for veterinarians supplying PARs
Veterinarians supplying PARs must meet the obligations imposed on them by relevant state Acts and Regulations. These include the Poisons Act (or equivalent), the Veterinary Surgeons Act, and Stock Foods and Medicines Act (or equivalent).
Contrived arrangements between veterinarians and wholesalers that attempt to circumvent legislation are not permitted and may jeopardise both the wholesaler’s authority and the veterinarian’s registration.
Responsibilities of the veterinarian
Responsibilities of veterinarians supplying PARs within the pig industry are detailed below.
Veterinary care and supervision of recipient livestock
Before pig veterinarians can supply PARs, they must be practising their profession. To do this, the veterinarian must meet the following criteria:
- The pig herd must be under the care and supervision of the veterinarian; this care and supervision should be real and not merely nominal.
- The treatment recommended and the drugs supplied must be recorded.
- The client must be advised of the correct usage of the drugs.
When given responsibility for the health of the animal or herd in question by the agent or owner, the veterinarian demonstrates care and supervision by at least either:
- having seen the animal or herd for the purpose of diagnosis or prescription immediately before supply or
- having visited the farm or other premises on which the animal or herd is kept, sufficiently often and recently enough to have acquired from personal knowledge and inspection an accurate picture of the current health state of the farm or premises; this must be sufficient to enable him or her to diagnose or prescribe for the animal or herd in question.
Areas of responsibility
In situations where a veterinarian is called on to prescribe or supply PARs, responsibilities to be taken into account (in addition to legal obligations) are:
- the care and welfare of the pigs that are the subject of the proposed drug supply
- the professional responsibility of the veterinarian as described by the Professional Code of Conduct of the Australian Veterinary Association (AVA).
The PARs drug supply chain
Veterinarians should carefully analyse the drug supply chain and distinguish wholesale from retail activities. They should also check the bona fides of persons to be supplied. All veterinarians involved in the supply chain of PARs should continually update their knowledge of individual or corporate entities that are registered as authorised or licensed veterinary wholesalers. State departments of health maintain current lists of wholesale dealers authorised, licensed or permitted under regulations of their state’s Poisons Act (or equivalent).
Off label/unregistered chemical use
Off label and unregistered chemical use in pigs is restricted in all states and territories. It is recommended veterinarians review relevant control of use legislation in the relevant state or territory in which they are practising.
Off-label or unregistered chemical use is intended to be limited to situations where there is no alternative registered veterinary chemical product available.
Off-label use pertains to the use of an APVMA registered veterinary chemical product contrary to a label direction or in a species for which it is not registered. Unregistered chemical use pertains to the use of a chemical not registered by the APVMA. Unregistered chemicals may include human medicines, companion animal medicines and veterinary compounded products.
Off label controls in pigs limits the veterinarian to using either products registered for use in pigs in a way different to label directions (e.g. altered dose rate) or the use of a product registered in another ‘major’ food producing species in most states and territories. Review relevant state or territory regulations for specific details on off-label use.
In all states, unregistered chemical use is permitted in only single animals unless a permit is provided by the APVMA, or in certain states written Chief Veterinary Officer approval has been obtained.
In both instances a written veterinary statement to the client which includes an appropriate withholding period must be provided, preferably signed by the owner to ensure they understand its’ implications. A copy of this statement must be kept by the veterinary practitioner for three years.
Contact the relevant state or territory Chemicals Coordinator for more information regarding off label and unregistered use of chemicals in pigs. [https://apvma.gov.au/node/309]
Veterinarians should meet the definition of ‘professional intervention’ in the supply chain for PARs. ‘Professional intervention’ can be defined as intervention between the drug wholesaler and the end user of the substance in such a way as to ensure that the drug is necessary, appropriate and will be used correctly.
Veterinarians must not act as ‘rubber stamps’ for transactions between wholesalers and end users, but should be fully involved in the disease treatment or control program requiring the use of PARs.
Documentation of professional intervention
The involvement of the veterinarian in the supply of PARs must be fully documented. Professional intervention should include the use of:
- the veterinarian’s own stationery or their stamp on invoices, prescriptions, authorisations and orders
- the veterinarian’s obvious recorded direction to supply.
When supply is made, the veterinarian must ensure that each pack or bottle of the PAR bears labelling as required by law, including the name and address of the veterinarian and the name of the pig farm.
Instructions on drug usage must be given to the end user by the veterinarian, with clear details of the method of administration, dose rate, withdrawal times and so on. These instructions can refer to specific disease control literature provided by the veterinarian.
Clinical records justifying the supply records of the names and quantities of PARs supplied, together with the name and address of the pig owner, must be kept for 2 years (3 years in Victoria).
Drug ownership during supply
There is no obligation for the veterinarian to own the drugs he or she is supplying or is responsible for supplying.
Stocks of PARs on farms
The supply of PARs for animal use to an end user, other than by a veterinary surgeon or by a pharmacist on a veterinary prescription, is illegal (see above). PARs stocks legally dispensed by a veterinarian for use on a pig farm are commonly stored in a central drug store. The storage of non-dispensed PARs on farms remote from the veterinarian (e.g. the storage of unlabelled or un-prescribed PARs in a locked area with access exclusive to the veterinarian), is considered outside the spirit of the Poisons Act and a contravention of the Veterinary Surgeons Act, in that the veterinarian would have difficulty in demonstrating that they maintain absolute control over these stocks.
Emergency supply of PARs
In cases of emergency where PARs are urgently required, delays may occur if drugs have to be sent to the veterinarian by the wholesaler before being dispatched to the end user. However, only in South Australia is there legal provision for a wholesaler to despatch directly to the end user on authorisation (oral, followed by written) from the veterinarian ordering the drugs.
The veterinarian (including those in the employ of a feed mill) must show professional intervention in the supply chain of the PARs to the end user via a feed mill. In effect, the feed mill acts as an agent for the veterinarian by acting on his or her order or authorisation; this is similar to a pharmacist refilling a prescription for a veterinarian.
Veterinarians employed by a company
Companies may be directly involved with the pig industry, either by direct ownership of livestock or by manufacturing PARs likely to be used within the industry, or both. Such companies may employ veterinarians whose responsibility may be either the health care of company-owned livestock or to provide technical expertise in the use of PARs in pigs.
Veterinarians employed by a company that is directly involved in ownership of pigs, or is an authorised, licensed or permitted wholesaler of PARs, have the same obligations as any other veterinarian. They must still meet their obligations under the various state Acts and Regulations pertaining to the use of substances and to their own professional activity.
Veterinarians have an obligation to point out to their employers any contravention of the Regulations affecting the supply or use of PARs and should make every effort to have these contraventions eliminated.
The existence of a wholesale drug purchasing arm in a company does not allow that company to indulge in retail supply to end users (including its own stock). There should be neither direct supply nor appearance of direct supply of PARs by the wholesale arm of a company to outside customers, franchises (unless they also hold a wholesale authority, licence or permit), the company’s own piggeries or contract growers. All are end users and can be supplied only by a veterinarian, who must intervene in the supply chain of PARs and demonstrate professional intervention as described above.
When the company’s wholesale arm supplies a company veterinarian, the veterinarian takes on the obligation to record transactions. PARs supplied to the company veterinarian (or any other veterinarian) must be held physically separated from the company’s wholesale drug supplies. They should be kept in a locked cupboard or room that is accessible only to the veterinarian. The veterinarian is required by law to keep a record of drugs they subsequently supply.
Other relevant policies and codes of practice
Date of ratification by AVA Board: 24 July 2014