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Teagasc - The Irish Agriculture and Food Development Authority

Safe Use of Livestock Medicines For Cattle and Sheep Farms

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The Key Points

Irish producers have a very good food safety record regarding livestock medicines. Misuse of livestock medicines however can cause various problems. This booklet provides producers with a detailed guide to the best practices required. The critical points to observe are:

  • Develop a herd health plan to minimise disease problems in the first place.
  • Use only approved products licensed for use with the particular species.
  • Only purchase from suppliers authorised to sell the particular remedy.
  • Administer medicines only if you are competent to do so.
  • Read the label carefully before you treat the animal.
  • Note manufacturer recommendations, precautions, contraindications and warnings.
  • Adopt good hygiene practices when injecting animals.
  • Check and note the withdrawal period for the livestock remedy.
  • Record the relevant details in the Animal Remedies Record.
  • Do not sell or supply milk or livestock until all withdrawal periods have elapsed.
  • Provide good handling facilities for safe administration of livestock medicines.
  • Store medicines in a suitable secure place.
  • Dispose of unused medicines and used needles in a safe manner.

Introduction

Animal medicines, including vaccines, play an important role in the control and prevention of animal disease. There are strict controls governing the authorisation, distribution and use of animal medicines. Ensuring product safety at all points in the chain from the `manufacturer to the animal' is essential. This includes the supply, storage, use and disposal of animal medicines.

Adherence to best practice is a key requirement at all points in the food supply chain. Producers are required to demonstrate best practice in regard to animal medicines.

This Safe Use of Livestock Medicines guide provides farmers with an overview of key regulations, farm assurance requirements and recommended best practice at farm level.

Medicines: The Potential Risks

Food safety can be compromised if livestock medicines or veterinary equipment are misused or best practice is not adopted. Three types of food safety hazards are associated with livestock medicines:

  • Chemical
  • Biological
  • Physical

Chemical Hazards

Residue contamination is the most likely chemical hazard. Medicine residues can render a product (milk, meat) unsuitable or unsafe for its intended use.

  • Once a residue occurs it cannot be removed.
  • It is vital to be aware of and fully comply with the stated withdrawal dates for a particular remedy.
  • It is an offencenot to observe the proper dose rate and withdrawal period stated on the product label.
  • It is illegal to sell animals or produce before the withdrawal period for any animal remedy administered has expired.

In the dairy sector, heavy industry fines can be imposed on producers if harmful residues contaminate milk. The Department of Agriculture and Food (DAF) and the meat plants operate residue monitoring programmes in abattoirs. These programmes combine random sampling of all animals and targeted sampling of suspect animals. Detection of harmful residues can have significant financial and legal implications for the producer. Fortunately the occurrence of animal remedy residues is very low. Producers need to be constantly vigilant however.

Biological Hazards

Bacterial or parasitic resistance to medicines can pose an overall threat to human and animal health. Resistance can occur if human or livestock medicines are misused or overused.

  • Prevention is the best policy. Draw up a herd health plan. Use good management practice and strategic use of medicines to minimise disease and parasites.
  • Avoid unnecessary use of medicines. Use the right product to treat an ailment. Give the correct dose rate. Complete the full treatment programme if using an antibiotic or anti-microbial medicine.

Physical Hazards

Broken needles in a carcase could give rise to food safety hazards. The frequency of needles entering the food chain is extremely low. The damage potential is very high if needles do enter the food chain.

Other Hazards.

While food safety is the primary concern; other significant hazards can also occur. These include risks to personal safety, animal health and welfare, and the environment.

  • Producers should handle all veterinary medicines with care. Extra caution is required for products where user contact with the medicine can readily occur. This includes sheep dips, pour on medicines and certain vaccines.
  • Unauthorised mixing of medicines together, or administering certain drugs at the same time could potentially cause harmful interactions for the animal. The stated withdrawal periods may also be affected.
  • Needles used more than once are not sterile and can damage or blemish meat. Damaged or burred needles may also damage meat and inflict pain to the animal.
  • Forceful use or misuse of dosing guns can damage the animal's mouth and pharynx. Care is required with worming bullets or boluses; significant injuries or even death can occur if calves are below the recommended age or weight or if incorrect applicator guns are used. Rough use of intra-mammary tubes can damage the teat orifice and canal. Broken needles compromise animal welfare if not removed.
  • Careless storage or disposal of livestock medicines can harm the environment. Particular care is required with the disposal of spent sheep dips.

The following guidelines will minimise the risk of serious food safety, animal health, environmental and personal safety hazards arising.

Guidelines for Safe Use.

Correct use of medicines is in the producer's and the customer's interest. A number of points should be noted when administering medicines.

Use the right product

  • Use licensed products. Livestock medicines must go through a licensing procedure and receive a national or EU registration number. The registration number will be displayed on the label of the medicine as well as on the container and associated packaging. The Irish Medicines Board website publishes an updated list of licensed veterinary medicines each month (www.imb.ie).
  • Always check that the medicine is licensed for use for the particular category or species of animal involved and is suitable for the condition being treated.
  • Medicines come in different formulations; a cattle wormer may be totally unsuitable for sheep because the concentration of active ingredient is different. Many fluke doses are unsuitable for cows near calving or in milk.
  • There are different classes of wormers and flukicides available. The particular active ingredient in wormers/flukicides may determine when and how the product should be used. Some flukicides for example are most effective against mature fluke only while others are effective against immature and mature fluke. If necessary get advice on the product most suited to your needs.
  • Only purchase from a supplier authorised to sell the particular remedy.
  • Do not purchase medicines if the label has been tampered with.
  • Do not `borrow' prescription medicines (e.g. antibiotics) from other producers.
  • Never use a prescription medicine on animals other than those it was prescribed for unless you have clear approval from a vet.
  • Check the expiry date on the product. Do not use any medicine past its expiry date. Observe any in-use expiry dates. Some vaccines may lose potency within hours of opening. Other medicines may lose potency within days or weeks of opening.
  • Consult your vet on the most appropriate intramammary antibiotics for mastitis control/treatment in your herd. Have a planned mastitis control programme targeting all factors likely to impact on herd mastitis levels.

Administer with care

  • Read all the instructions carefully, as they contain important information.
  • Comply with the manufacturer's dosage guide. Under dosing increases the risks of parasites or bugs developing resistance to livestock medicines. Overdosing may increase the risk of residues occurring or adversely affect animal health.
  • Competent individuals should administer livestock medicines (e.g. someone who can adequately assess or check animal liveweight to determine the dose rates and follow the manufacturer's instructions).
  • Always complete the specified treatment programme if using antibiotics or an anti-microbial.
  • Do not mix medicines or wormers with other medicines or mineral vitamin supplements.
  • Injectable medicines are normally given as subcutaneous (under the skin) or as intramuscular injections. Follow the manufacturer recommendations
  • Do not inject cattle in the valuable meat areas. There is always a risk of an abscess forming or damage/blemishes occurring. The most valuable cuts are in the loin area and the hindquarter area. Forequarter cuts (shoulders/neck) are generally less valuable.
  • In the rare event that a needle breaks during an injection the needle should be removed promptly. Veterinary assistance may be necessary to remove broken needles in a safe, hygienic manner. A broken needle can lead to significant hazards further along the food chain. It also compromises basic animal welfare requirements.

Provide suitable equipment and facilities

  • Proper livestock handling/restraining facilities are vital to administer medicines safely and correctly.
  • Check that dosing or injection guns are properly calibrated to deliver the correct dosage.
  • Damaged or worn equipment (e.g. dosing guns) can inflict unnecessary stress and injury on stock and constitute an animal welfare hazard. Do not use excessive force or handle animals roughly.
  • Make sure animals are at the recommended age or weight if using boluses or bullets. Use the correct applicator gun.
  • Replace needles if they are damaged.
  • Follow manufacturer or veterinary instructions in relation to needle size (gauge) required for specific situations.

Ensure Good Hygiene

  • Use a sterile needle for each injection if at all practical. Used needles can cause tissue damage and inflict pain on the animal.
  • Use disposable needles and syringes if treating potentially infectious or transmissible diseases.
  • Make sure that the injection site is clean and the injection needle is kept clean. Use a separate clean sterilised needle to fill the syringe from the bottle or container if giving more than one injection.
  • Sterilise needles and syringes in boiling water for 20 minutes (or use alcohol or a suitable sterilising agent). Alcohol or disinfectants are not recommended to sterilise needles or syringes if using certain vaccines. Check the manufacturers' recommendations on this point.
  • Automatic reloading injection guns are widely used for overall herd or flock treatments (e.g. flock vaccination). Manufacturers generally give specific recommendations on how often needles should be changed, how needles are sterilised and how the automatic syringe is calibrated. Follow these instructions carefully.

Watch the withdrawal date

  • Always read the label and check the product withdrawal period. The information on product labels and literature can change as new information becomes available. The product authorisation criteria or maximum permitted residue levels in meat or milk may have been amended.
  • Record the use of the medicine in the Animal Remedies Record. Comply with the withdrawal period.
  • Producers should segregate the animal identity cards of treated cattle for the duration of the remedy withdrawal period. This will prevent accidental or inadvertent sale of animals within the withdrawal period.
  • Use a marking stick or spray to identify treated livestock that are not normally tagged or individually identified.
  • Animals that have failed to respond to medication for a particular condition (e.g. mastitis in cull cows) must not be sold until the withdrawal period for medicines administered has elapsed.
  • Ensure that residue contaminated milk does not enter the milk bulk tank or food supply chain. Do not feed this milk to any livestock.
  • Remember residue monitoring is carried out on an ongoing basis at meat and dairy processing plants. Accidents or negligence could prove to be a costly mistake and may be harmful to consumers.
  • Make sure that someone on your farm is personally responsible for ensuring that withdrawal periods are observed.

Protect yourself

  • Ensure that family members and farm employees are aware of any risks to personal health and safety.
  • Inexperienced or trainee operators should be directly supervised until they become competent.
  • Manufacturer instructions and safety guidelines (e.g. protective clothing, gloves and masks) should be complied with.
  • Personnel should not eat food or smoke while handling and administering livestock medicines.
  • If splashed (e.g. skin splashes, splashes in the eye); follow the manufacturer guidelines. If medicines are accidentally ingested or swallowed consult your family doctor. Specify the name of the product involved, the active ingredient and any manufacturer recommendations given.
  • Keep a list of emergency phone numbers on hand (e.g. family doctor, local hospital, veterinary surgeon, pharmacist).
  • Suitable handling and restraining facilities are essential to minimise the risk of physical injury to the animal and the operator.
  • Take extra care when treating sick animals. They maybe carrying bugs that can spread to you. Wear protective clothing if necessary. Cover or protect any open wounds or sores likely to come in contact with the animal. Practice good hygiene - always wash your hands after handling animals and before eating food.

Report Adverse Reactions

Adverse reactions to animal medicines may occur in certain circumstances. These can include negative reactions in the animal, suspected lack of medicine efficacy (effectiveness) or unexplained /unanticipated residue problems. Adverse reactions are unusual but should be reported to your vet if suspected. Your vet should report the problem to the Irish Medicines Board (IMB) if there is reasonable grounds to do so. Adverse reactions can potentially occur in humans coming in contact with animal medicines. Report any suspected reactions to your doctor. Your doctor should report genuine suspect cases to the IMB. The IMB provides special reporting forms for this purpose. Monitoring and investigating adverse reactions to medicines is an important responsibility of the IMB. Reporting adverse reactions will help the IMB ensure that authorised medicines continue to be safe and effective and carry the most up to date accurate information on labels and accompanying literature.

The Animal Remedies Record

Producers are legally obliged under Regulation 42 (2) of the Animal Remedies Regulations, 1996, to record the administration of all animal remedies having a withdrawal period.

This requirement applies to all animals reared for food production. In practice, details for the vast majority of animal remedies administered or given to farm animals will need to be recorded in the Animal Remedies Record.

The particular remedy details must be recorded in an Animal Remedies Record book. The herd or flockowner (or person in charge) is responsible for maintaining the Animal Remedies Record irrespective of who actually administers the medicines.

Completing the Animal Remedies Record

  • Relevant details must be recorded in the record book every time a product with a withdrawal period, or a Prescription Only Medicine (POM) or a Veterinary Surgeon Only (VSO) product, is used.
  • The format required and content of the DAF Animal Remedies Record must be followed. Producers are not legally obliged to use the DAF issued book itself when recording the use of remedies. However, they must use a book that records the details specified in the DAF Animal Remedies Record
  • The vet should complete and sign the Animal Remedy Record if he/she administers a VSO remedy or supplies or administers a POM product. Any subsequent administration of the POM product by the herdowner/stockperson (as permitted by the veterinary prescription) must also be recorded in the Animal Remedies Record.

Animal Remedies Regulations 1996

Details to be kept in accordance with Regulation 42(2)

Date of Administration

Name and quantity of animal remedy administered

Identity of animal to which animal remedy is administered including eartag number where appropriate

Date of expiry of withdrawal period (if any)

Name of person who administered the animal remedy

Name of prescribing Veterinary Surgeon (if applicable)

Name of supplier of Animal Remedy

The following points should be noted when completing the Animal Remedies Record:

  • The identity (e.g. eartag no.) of the animal treated should be entered
  • Where all stock within a distinct group/batch of animals (e.g. all weanlings, all suckler cows, all finishing steers) are treated with the same product at the same time the individual eartag numbers need not be entered. However, sufficient information should be provided in the Animal Remedies Record so that the group of animals and individual animals within the group can be traced in the accompanying Bovine Herd Register.
  • Where animals are not individually tagged individual animals treated should be clearly identified using a marking stick or spray marker or other suitable identification method.
  • Records must be kept in the order that events occur

The Animal Remedies Record must be kept available for inspection for a period of not less than three years. The Regulations require that the Animal Remedy Record details must be kept in a book. Computerised records are not in themselves sufficient under the current provisions of the Regulations.

Medicine Storage

Secure, separate and safe storage of medicines and equipment (e.g. needles) is important.

Suitable Storage

  • The medicine store(s) should be of a sufficient size and strength to hold all the livestock remedies on the farm.
  • Store livestock medicines in accordance with manufacturer instructions. Some medicines may need to be stored within a specified temperature range. (e.g. vaccines) and may require refrigeration. Medicines from a refrigerator that were inadvertently frozen should be discarded.
  • The medicine store should not be located in direct sunlight or adjacent to any source of direct heat.
  • The medicine store should be located indoors (e.g. in an adequately lit shed)

Safe Storage

  • Livestock medicines must be kept out of the reach of children.
  • The medicine store should be locked when not in use. The key should be kept in a safe location. All farm workers should know the store location.
  • The medicine store should contain a clear warning label.
  • Do not store medicines in close proximity to animal feed. Any medicated feed (if prescribed) should be clearly labelled and stored away from ordinary feed.
  • Dairies are an unsafe place to store medicines, accidental contamination of milk could potentially occur.
  • Do not store medicines near household food (e.g. deep freezes, fridges) in case of accidental contamination of food.
  • Store medicines separately to other farm chemicals (e.g. weedkillers, disinfectants). Animals have been poisoned where farm chemicals were given by mistake.
  • Segregate and preferably remove expired medicines from `in use' medicines.
  • All spillage's should be removed immediately from the medicine store and disposed of in accordance with manufacturer recommendations.

Disposal of Medicines/Materials

Safe disposal of veterinary medicines and materials is important for environmental and human safety reasons. Used needles, syringes and certain medicines may be regarded as hazardous waste under the Waste Management Acts 1996 and 2001. Care should be taken with the disposal of potentially hazardous waste.

Do not

  • Do not hoard partly used or expired medicines.
  • Never sell or pass on unused medicines to any one else
  • Do not dispose of unused or out of date medicines and used needles: in domestic rubbish, down drains or watercourses or into household sewage.

Used Needles (Sharps)

  • Used needles (sharps) should not be stored or disposed of in a manner that may compromise the health and safety of humans, the health and welfare of animals or harm the environment.
  • Farm containers may be suitable for temporarily storing used needles and syringes. These containers should be robust, and have a narrow opening with a cap or cover to protect people from accidental contact or prods (e.g. empty oil drum or used silage additive containers).
  • Used needle containers should carry a clear warning label and be kept out of children's reach.
  • Specific sharps containers are available from commercial hazard waste collectors for a fee.
  • Sharps should not be buried or burned on the farm
  • Dispose of full needle containers using recognised disposal methods such as:
    • designated hazardous waste collection facilities provided by local authorities.
    • approved private licensed hazardous waste collection services (collectors must have a valid Waste Collection Permit).

Used/Partly Used Medicines

Partially used or expired medicines such as antibiotics should be disposed of as described above for used needles. Individual veterinary surgeons or pharmacies may agree to dispose of partially used or expired medicines for their clients. However there is no requirement that they do so.

Empty animal remedy containers should be disposed in line with manufacturer recommendations and in compliance with environmental regulations (and with the Rural Environmental Protection Scheme (REPS) requirements where applicable).

Spent sheep dip is also classified as a hazardous waste and can cause significant environmental damage if disposed of improperly. Producers must follow the national regulations and guidelines relating to sheep dip disposal.

Farm Assurance Schemes

Industry quality assurance schemes are vital when promoting Irish food in key markets. Adequate records of animal remedy usage are a key requirement for the farm assurance element of these schemes. Specific schemes may require more detailed information over and above the existing legal requirements (e.g. producers may be required to maintain medicine purchase records in addition to medicine usage records).

Farms cannot be deemed to be farm assured if there is major non-compliance in relation to livestock medicines. Quality assurance schemes also require producers to adopt good practices in relation to the storage and disposal of medicines.

Appendix 1: Supply and use of Medicines

Detailed national regulations (e.g. Animal Remedies Act 1993, and subsequent Animal Remedies Regulations) control the supply and use of livestock medicines. All livestock medicines must go through an evaluation and authorisation procedure controlled by the Irish Medicines Board or the European Medicines Evaluation Agency. Nationally approved medicines carry a Veterinary Product Approval (VPA) number. Medicines approved centrally by the EU Commission carry a Community Registration (EU) number.

Key terms and requirements used in the regulations are summarised under the following headings:

  • Legal Designation of Remedies
  • Legal Routes of Supply
  • Label Regulations
  • Prescription Regulations

Legal Designation of Remedy

Legal "Route of Supply"

VSO
(Veterinary Surgeon Only)
Example: Local anaesthetics used for disbudding/castration

Not available to Producer

Must be administered by Veterinary Surgeon or under his/her direct supervision ( i.e. vet is present at administration)

POM
(Prescription Only Medicines)
Example: Antibiotics, Prostaglandins.

Products to be supplied by a Veterinary Surgeon or obtained from a pharmacy on foot of a veterinary prescription.

(See further requirements under "Prescription Regulations" of this leaflet)

POM (E)
(Prescription Only Medicine (Exempt))
Example: Certain preparations/ointments and vaccines.

Available from veterinarian or through a pharmacy from a pharmacist

PS
(Pharmacy Only)
Example: certain ointments (e.g. eye ointment) and medicines

Available from veterinarian or pharmacy under the supervision of a pharmacist

LM
(Licensed Merchant)
Example: Anthelmintics (wormers)

Available from veterinarian, pharmacist or licensed merchant

Label Regulations

Veterinarians and pharmacists must attach a label (e.g. to the bottle/container) for any POM, POM (E) or PS medicines that they supply to farmers. This label must contain the following minimum details:

  • Farmers name, address
  • Veterinary Surgeon's (or Pharmacist's) name
  • Date of supply

In addition the following details should be included on the label if not already specified on the product/packaging;

  • product name, active ingredient, administration method, dose rate, withdrawal period, a description of the animal to be treated

The veterinarian or pharmacist label provides supply chain traceability for these categories of medicines. It is in the producer's interest that these regulations are observed.

Prescription Regulations

POM products can be supplied by a veterinary surgeon. A veterinary prescription is required to purchase POM products from a pharmacist.

The initial POM supply or prescription for treating a particular condition in an animal can only be issued after the vet conducts a clinical examination of the animal(s). A vet can only supply a POM product or issue prescriptions for animals `under his/her care'. Veterinary `care' means that the vet (or a colleague from the same practice) is:

  • familiar with the current overall health and condition of the herd,
  • has been consulted by the herdowner (or person in charge) and been given veterinary responsibility for the animals

A vet can subsequently supply a POM product or issue a prescription without further clinical examination for cohort animals (animals from same group) if:

  • the cohort animals display the same disease symptoms within 7 days of the initial clinical examination,
  • the vet is satisfied that it is the same health condition or disease outbreak that is affecting other animals in that group/shed/farm.

Procedures for repeat supply/prescriptions required for ongoing disease or chronic health problems in an animal are also regulated. The veterinarian should not prescribe more than a 31-day supply of a POM product.

Where a vet issues a prescription (to purchase a POM from a pharmacy) it should contain:

  • the name of the medicine or remedy
  • the manner or site of administration
  • the dose rate and withdrawal period
  • a description of the animal(s) involved
  • the period or number of administrations the medicine is valid for
  • the name and address of the farmer and the prescribing vet

The vet should provide the farmer with the original prescription and one copy. The original is given to the pharmacist. The farmer is obliged to retain the copy of the prescription for three years.

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