VN April 2022

Vetnuus | April 2022 26 Extra label use of medicines for the treatment of veterinary patients is a reality. Exotic animal practices and wildlife practices would not be able to function if they could not use drugs extra-label. However, it is a high-risk activity, and veterinarians should know their rights, responsibilities, and risks associated with this practice. 1. Veterinarians are allowed to use medicines extra-label, but there must be a justifiable reason for doing it. This means that there should not be another approved drug for the intended use, or that the approved drug is not available in the dosage or formulation you need, or does not have the active ingredient you require, etc. 2. The principles apply to both medicines registered under the Medicines Act (Medicines and Related Substances Control Act, 1965, Act No.101 of 1965) and medicines registered under the Stock Remedies Act (Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act 1947, Act No. 36 of 1947). 3. Extra label use includes any application not listed on the package insert of the registered medicine. This means that any use in species not listed is extra-label use. Changes to dosages, the frequency and routes of administration, and reformulation of the medicine even in species listed on the package insert are regarded as extra-label use. Using medicine for any disease or condition other than those listed in the package insert is extra-label use. 4. The veterinarian has full responsibility for the preparation, application, and outcome of the application of the medicine. This also means that the veterinarian must be available to intervene or advise if the patient has an abnormal reaction. Essentially this also means that there must be a valid veterinarian-client-patient relationship. 5. Informed consent from a client is needed before administering a medicine extra-label if there is any concern about a potentially aberrant reaction. 6. Extra label use of the prohibited substances in food- producing animals is also prohibited. 7. When using medicines extra-label, veterinarians must still comply with all the other legal requirements for the use of the medicines. Awareness of these principles and applying them in your practice shouldprotect you from issueswith the extra-label use ofmedicines. If you have any further questions in this regard, please get in touch with me at trudie@legalvetservices.co.za. v SAVA Legal Column 7 FACTSVETERINARIANS MUST KNOW ABOUT EXTRA-LABEL MEDICINE USE Dr Trudie Prinsloo, Legalvet Services; E-mail: trudie@legalvetservices.co.za