There is a trend towards increasing controls over the veterinary use of drugs in animals across the European Union (EU). Beginning January 1, 2006, feed grade antimicrobial growth promoters are banned throughout the EU. Member countries are also imposing additional restrictions on the therapeutic use of antimicrobials as well. As an example of the controls governing veterinary and farmer use of drugs in food-producing animals we explore the Danish regulations.
In this article, we are concentrating on regulations governing the use of drugs in food-producing animals in Denmark. However, the regulations also involve companion animals, horses and fur-producing animals as well to varying degrees.
Since 1990, Danish veterinarians have not been allowed to dispense drugs. Distribution of veterinary pharmaceuticals can only occur from licensed pharmacies. All drugs except vitamins, certain ectoparasiticides, and mineral complexes are considered prescription-only and can be obtained only from a pharmacy or a veterinarian. A veterinarian may maintain an inventory of drugs obtained from a pharmacy and may dispense those drugs to a farmer for the treatment of animals under his/her care only under certain circumstances. Feed mills may also inventory a supply of medicated premixes for the purpose of manufacturing medicated feeds which can be distributed to farmers on a veterinary prescription. The distribution of veterinary vaccines is also tightly controlled and may be distributed only by pharmacies or the National Veterinary Institute.
All use or distribution of prescription-only drugs for use in food-producing animals must be recorded by the veterinarian and reported to an official database called Vetstat. The information reported must include information on the veterinarian responsible for the treatment, the drug prescribed, identification of the target herd, and the species (including age-group and disease-group) to be treated. The farmer must record the animals treated, drugs used, dates reason for treatment, dosage and administration route, responsible person, and the origin of the drug (if not dispensed by a veterinarian). Records must be kept for at least 5 years.
The extra-label use of drugs is also tightly controlled. By regulation, a veterinarian must use veterinary medical products labeled for use in animals. However, if a registered product does not exist, a veterinarian may, for a single animal or small number of animals, prescribe: 1) a veterinary product labeled for another animal species or for the same species but for a different disease, or, if this does not exist, 2) a human drug, or, if this does not exist, 3) a compound prepared by a pharmacy on a prescription from a veterinarian. A Maximum Residue Level (MRL) must be established for the drug’s active ingredient and for the animal species concerned.
Certain compounds are not allowed for use in food-producing animals such as hormones (including somatotropins) for growth and yield promoting purposes, and beta-agonists and substances with estrogenic, androgenic, and gestagenic effect (except for therapeutic purposes provided a number of additional conditions are met). In addition, certain drugs may only be used if administered by the veterinarian in person. Examples of these drugs include: injectable analgesics, anesthetics, injectable selenium-containing products, oxytocin and analogous compounds to enhance parturition, progesterones, and prostaglandins.
Farmers may enter into Contracts for Health Consultancy with a named veterinarian which is registered with the regional veterinary officer. For swine producers, this agreement requires 12 consultations per year. The veterinarian then may prescribe drugs for the following 35 days if the necessity for further treatment has been established, if the reason for further treatment is described, and if initiatives have been agreed upon with the producer in order to solve the problem. This contract also allows the veterinarian to dispense drugs to treat adult cattle for 5 days or one treatment of an infected mammary gland in dry cows. It is required, however, that the veterinarian initiates the treatment in person.
In addition to the regulations outlined above, the Danish authorities have reportedly developed a list of disease conditions and prioritized a "suggested" list of approved therapeutics that veterinarians should follow when treating diseases. As an example, the use of macrolides, such as Tylan, is discouraged suggesting instead the use of Tiamulin which is not used in human medicine. If the veterinarian wants to use a macrolide for instance, or otherwise deviate from the "suggested" list, he/she must have a very good argument for doing so and define in writing the reasons for the deviation.