GOOD PRACTICES FOR THE USE OF VETERINARY PRODUCTS
GOOD PRACTICES FOR THE USE OF VETERINARY PRODUCTS
The Good Practices for the Use of Veterinary Products comprises both the prescription and the responsible use of veterinary products.
The objective of this document is to disseminate appropriate ways to prevent and cure animal diseases using current technology and to improve the zootechnic indices of production animals through the rational use of veterinary products as established during their registration, respecting and applying the recommendations on the label, to reach the expected results and preserve animal and human health and the environment.
This document also complements what has been established in Chapter 6.10 of the Animal Terrestrial Health Code, concerning the directives for the responsible and prudent use of antimicrobial products in veterinary medicine, extending it to the veterinary products most commonly used, with special emphasis on the responsible use and administration of these products.
Objective and Scope
Objective: To establish directives for the correct use of veterinary products, including biological products and ectoparasiticides used in production and companion animals.
Scope: Veterinarians and people responsible of administering these veterinary products.
Terms and Definitions
Veterinary Product: Any substance applied or administered to any food-producing animal, such as meat or milk producing animals, poultry, fish or bees, whether used for therapeutic, prophylactic, or diagnostic purposes, or for modification of physiological functions or behaviour. (CAC/MISC 5-1993)
Good Practices of Use: Official recommended or authorized usages and practices approved by national authorities, including withdrawal periods, of veterinary drugs under practical conditions. (CAC/MISC 5-1993)
Expiration date: Date up until which the manufacturer can guarantee the quality of a specific product is maintained.
All products are subject to testing to determine their expiration date. After their expiration, the stability is impaired (damaged) and the efficacy is compromised.
Commercial trade name of a product: Is the name of the commercial product. The brand is proprietary to the manufacturer. In addition to the trade name, the label must contain the generic name of the active moiety(ies) as described in the DCI – Common International Denomination.
Generic name: Is the name of the drug or active moiety. The generic name identifies the substance that has the main effect in the veterinary product. In the case of biological products – vaccines, for example – it is the name of the etiologic or pathologic agent.
Dose: Is the amount of product necessary to achieve the therapeutic response and, therefore, is efficacious.
Dose regime: includes, besides the dose, the frequency of use and length of the treatment.
Pharmacokinetics: describes the absorption, metabolism and excretion of the active moiety of a medicinal product. It consists of the transit of the product through the animal’s body, including the period between doses, and concentration changes in tissues as a function of time following administration.
Withdrawal Time and Withholding Time: This is the period of time between the last administration of a drug and the collection of edible tissue or products from a treated animal that ensures the contents of residues in food comply with the maximum residue limit for this veterinary drug (MRLVD). (CAC/MISC 5-1993).
1. Good Practices of Use common to veterinary products
1.1. Only registered products should be prescribed or applied to animals. Before a product is marketed for use, it must be registered by the competent official organization, to determine if the product fulfills the technical requirements, especially safety and efficacy.
1.2. It is essential that the professional prescribing the product as well as the person in charge of administering it read the information contained on the label carefully.
1.3. The prescription for a veterinary product must include the trade name as well as the generic name of the active moiety or components of the formulation.
1.3. Before administering the veterinary product, it is necessary to confirm the following control points:
1.3.1. The existence of a registration number for the product given by the competent official organization
1.3.2. The integrity of the packaging material
1.3.3. The expiration date
1.4. The person responsible for administering the product must carefully read the dosing instructions given by the manufacturer as well as taking into account the prescription and directions given by the veterinarian.
1.5. The person responsible for administering the product must be attentive to the dose regime for the product, because the efficacy of a veterinary product is directly linked to a correct dose regime.
Related to the above, when using a veterinary product, the user must consider its route of administration, dose, number of doses per day, and length of treatment.
1.6. The use of veterinary products, when possible, will be restricted to those animal species for which the product is indicated. The pharmacokinetics may vary between different animal species. Therefore, the use of human products in veterinary medicine and applying the dosing period recommended for one species to another one is not recommended. In addition, formulations manufactured by unqualified personnel or compounded products should not be used in veterinary medicine.
1.7. If more than one product will be used simultaneously, it is important to read the insert accompanying the products carefully because some products should not be used in conjunction with others due to incompatibility, antagonism in their actions, or increased risk of adverse reactions.
1.8. The user must be especially careful and respect the withdrawal period indicated by the manufacturer, which is written on the label.
The use of the product must stop an appropriate amount of time before the slaughter of the animal or the sale of milk or eggs for human consumption. The withdrawal period must be rigorously observed to avoid the presence of residues of the veterinary products above the level considered dangerous for human health in food.
When a combination product is used, the withdrawal period will be the longer of the ones for each drug in the combination.
1.9. (This paragraph should include a different point of view according to each country’s regulations)
THE USER IS RESPONSIBLE FOR THE INCORRECT USE OF VETERINARY PRODUCTS
Depending on the local legislation, it can generally be said that the responsibility for the incorrect use of a veterinary product belongs to the user. In the case of Brazil, the Decree nº 5053 of 22 April, 2004 establishes the responsibility of the user as follows:
Art. 124 – In the case when the incorrect use by the buyer or the user of a product against the indications of use detailed on the labeling or the prescription made by the veterinarian is proven, the buyer and the user are liable to penalties established in the Legal Criminal Code.
1.10. Among the most common causes for the lack of efficacy of a veterinary product are:
1.10.1. Use after the expiration date;
1.10.2. Incorrect storage (i.e., excess of light, inappropriate temperature);
1.10.3. Treatment period too short and a relapse occurred;
1.10.4. Wrong diagnosis;
1.10.5. Wrong dose and/or indications;
1.10.6. Product administration was too late;
1.10.7. Resistance to the active moiety.
1.11. It is necessary to consider the following most common causes of adverse effects on human health:
1.11.1 Incorrect product handling and inadequate protection of the people handling the product
1.11.2 Insufficient withdrawal period
2. Good Practices of Use applied to vaccines
2.1. Points to consider prior to the purchase of vaccines
The decision to buy must not be made without evaluating the composition, quality and storage of the vaccine, which are important factors affecting the cost. In many cases, it is enough to prevent the death of one animal to compensate for the cost of vaccination for a significant number of animals. In the case of companion animals, the death of an animal may represent an inestimable value.
2.2. It is recommended that users consider the following precautions related to the purchase and correct storage of vaccines, considering that incorrect storage has a direct consequence on the efficacy of the vaccine.
2.2.1. Buy vaccines from a proper distributor.
Verify that the vendor has and uses equipment to control the maximum and minimum temperature of the refrigerator or freezing chamber, as well as the temperature of the vaccine at the time of purchase. Do not buy a product that has been stored in a freezer.
2.2.2. Transport the vaccines using ice or other refrigerants, carefully maintaining the containers well closed and taped to conserve the temperature.
2.2.3. Store the vaccines at the temperature recommended by the manufacturer, usually between 2ºC and 8ºC. It is recommended having a thermometer that indicates the maximum and minimum temperature in the refrigerator.
2.2.4. Maintain the vials in an isothermal box during transportation and administration of the vaccine, with ice or refrigerant, and always keep the box closed.
2.2.5. The syringe should not be exposed to ambient temperature – especially to sun – between applications, and should be maintained in the storage box.
2.2.6. Use the multiple dose vials completely and discard any residual product. The introduction of the needle into the vial to extract the vaccine normally introduces contaminants. When putting away the used vial, still in the storage box, the vaccine may loose its efficacy, and the risk of producing abscesses in the animals may be increased.
2.3. Points to consider during the application:
2.3.1. Calibrate and verify the calibration of the dosing gun used to apply multiple doses according to the animal species and type of product.
2.3.2. In the case of some products, the container must be agitated as indicated by the manufacturer.
2.3.3. The personnel responsible for administering the vaccine must comply with the steps to maintain sterility before and during the application.
2.3.4. The syringes and needles used to administer the vaccine should be either sterilized or disposable material. The hands of the person should be washed with soap and water. After using, the syringes and needles should be washed and sterilized, or discarded.
2.3.5. Evaluate the clinical state of the animals prior to their vaccination. Animals showing signs of disease or stress should not be vaccinated, unless otherwise indicated by the veterinarian. For an animal to produce antibodies and be protected, it is necessary that the animal is in good health and nutritional condition during and after vaccination. If the animal is stressed, sick, has parasites, or shows any nutritional unbalance, the capacity to develop an adequate immune response to the vaccine components is diminished.
2.3.6. Ensure that, once the vaccine has been administered, that the vaccine has been administered to the total number of animals that needed to be vaccinated. When an entire herd is vaccinated, the person administering the vaccine must be sure that all animals were vaccinated. This may be done by verifying that the number of doses applied corresponds to the number of animals in the herd.
2.3.7. Plan the vaccination with the objective of preventing the disease. Vaccines are preventive, not therapeutic. Therefore, vaccines must be always applied before the disease occurs and not during the course of the disease, unless the veterinarian indicates otherwise. After applying a vaccine, the body needs a certain time to produce antibodies that will give the necessary protection. In the period called “negative period of immunity”, the animal, although already vaccinated, is not protected against the pathogens causing the disease. That is why it is important to maintain the program (chronogram) and frequency of vaccinations.
2.4. The most common causes for lack of efficacy of the vaccines are the following:
2.4.1. Storage at the wrong temperature
2.7.1. Expiration date passed
2.7.2. Incomplete vaccination of the herd
2.7.3. Sick animals, either with infectious or parasitic diseases, lacking of nutritional elements, or stressed animals.
2.7.4. Incubation period of a disease.
2.7.5. Under-dosing due to lack of technique of lack of calibration of the dosing guns.
2.7.6. Lack of frequency of the recommended vaccination by the official organizations or by the vaccine manufacturer.
2.7.7. Deficient agitation of the vial to homogenize the product.
2.7.8. The route and place of administration indicated by the manufacturer of the product are not observed.
3. Good practices of use applicable to veterinary anti-parasitic products
3.1. Avoid the use of “made in house” formulations, agriculture products or products showing a damaged packaging.
3.2. Repeating the vaccination will be considered as a function of the evolutionary cycle of the parasite, the animal species, and the degree of infestation, and based on the diagnosis made by the veterinarian.
3.3. Follow the manufacturer’s instructions for the different formulations and routes of administration according to the following:
3.3.1. Injectable Products
126.96.36.199. Calibrate and sterilize the syringes. Make sure that the needles are in good conditions and sterile and that they are of the appropriate size for either sub-cutaneous or intramuscular administration.
188.8.131.52. Observe the route of administration.
184.108.40.206. Store the product according to the manufacturer’s recommendations, before and during its application, maintaining the product in a cool place and away from solar light.
220.127.116.11. If recommended, the vial should be agitated every time the syringe is filled.
18.104.22.168. To establish the correct dose, it is recommended that the animals be weighed when the dose is established on a kilograms of body weight basis.
22.214.171.124. Control the rate of vaccination of the animals because this is one of the factors that causes under-dosing, resulting in compromise efficacy.
126.96.36.199. Some products should be applied to fasted animals.
3.3.2. Products for oral administration
188.8.131.52. Ensure that the equipment is in good conditions, clean and calibrated.
184.108.40.206. Calibrate the dosing gun frequently, preferably every 10 (ten) animals.
220.127.116.11. Weigh the animals before the medication to ensure the correct dose.
18.104.22.168. Some products should be applied to fasted animals.
22.214.171.124. Take care when dosing to avoid a false route of administration of the oral products.
3.3.3. Products applied by spray and pour-on
126.96.36.199. Spraying baths
188.8.131.52.1. Carefully read the information on the label before opening the product. The recommendations may be different from one product to another with the same indication.
184.108.40.206.2. Always keep the containers closed, in a dry place, protected from sunlight and away from children.
220.127.116.11.3. When the application requires previous dilution of the product, the recommended volumes should be observed to avoid under-or over-dosing.
18.104.22.168.4. Always wear adequate clothing to handle the product, during the dilution (manipulating concentrated products) or during its application. It may be necessary to wear gloves or a protective mask.
22.214.171.124.5. The animals should be sprayed in the direction of the wind and preferably against the direction of the hair.
126.96.36.199.6. It is estimated that an adult bovine needs a minimum of 5 (five) litters of preparation to wet the entire animal, including the ears, folds, between the extremities, scrotum, and tail insertion adjust as appropriate for the different types of animals).
188.8.131.52.7. Spraying of the animals should not be done during the warmest hours of the day. It is preferably to start early in the morning or in the evening. Avoided spraying tired, thirsty or debilitated animals.
184.108.40.206.8. Dispose of empty containers according to the instructions of the manufacturer. Empty containers should not be re-used.
220.127.116.11. Products applied by pour-on
18.104.22.168.1. The recommended dose should be applied, consistent with the weight of the animal. Good pour-on formulations are marketed with an applicator.
22.214.171.124.2. Distribute the product according to the indications of the manufacturer. During its application, work from the base of the head to the insertion of the tail or as indicated on the label.
126.96.36.199.3. Pour-on is a topic application; this product should never be used by the injectable or oral route.
188.8.131.52.4. Avoid applying these products on wet animals, or during rainy days. In some cases a period of at least two hours should elapse between treatment and exposure to rain.
184.108.40.206. Products applied by immersion bath (ectoparasiticides)
220.127.116.11.1. It is important to follow the manufacturer’s recommendations concerning the preparation, and recharging of the immersion baths. The quality of the mix may interfere with the efficacy of the product.
18.104.22.168.2. Controlling the fullness of the bath ensures that the animals get totally wetted by the product.
22.214.171.124.3. Avoid bathing the animals on very hot and sunny days.
126.96.36.199.4. Once the animals have been bathed, they should return to their contaminated pasture in order to allow reduction the parasites in the environment.
3.4. Other general recommendations for the use of antiparasitic products:
3.4.1. If other products are being used, the information in the labels should be carefully read.
3.4.2. The containers and remaining antiparasitic products should be properly disposed of according to the manufacturer’s instructions. Any remaining products should not be discarded in rivers or other sources of water. The empty containers should be incinerated or buried strictly according to the manufacturer’s indications.
3.4.3. The persons using these products should avoid exposure to these drugs. Immediately following the application, they should take a bath. It is very important to use appropriate equipment and wear appropriate clothing. Avoid eating, drinking or smoking during the application of ectoparasiticide products.
Sindicato Nacional da Indústria de Produtos para Saúde Animal (SINDAN)
Cámara Argentina de la Industria de Productos Veterinarios (CAPROVE)
Level of approval
XII Seminar on Harmonization for Registration and Control of Veterinary Medicines– Panamá, Panamá, 2006: Approval of the above text (Step I)
XIII Seminar on Harmonization for Registration and Control of Veterinary Medicines, Santo Domingo, República Dominicana: 2007: Step III
XIV Seminar on Harmonization for Registration and Control of Veterinary Medicines, Asunción, República del Paraguay, 2008: Final Approval.
Terrestrial Animal Health Code (2009) - Chapter 6.10.
Responsible and prudent use of antimicrobial agents in Veterinary Medicine
CAC/MISC 5-1993, Amended 2003. Glossary of terms and definitions (Residues of Veterinary Drugs in Foods). Codex Alimentarius Commission, 26th Session.
CAC/RCP 38-1993. Recommended international code of practice for Control of the use of veterinary drugs. Codex Alimentarius Commission.