Guidance for authorisation of controlled drugs in veterinary medicine

this guidance provides clarity for veterinarians when authorising controlled drugs (cds) and deciding on the appropriate format and frequency for reviewing a patient’s medical progress, before authorising further supply cds are subject to a one month maximum period of supply per authorisation (with no repeats) due to their high risk and the regulatory requirements of the misuse of drugs act 1975 this does not mean a compulsory in person physical exam is needed every 30 days, but that a monthly veterinary consultation for a ‘medical progress re assessment’ is required for a veterinarian to maintain sufficient personal knowledge of the animal’s health, and to ensure the continued treatment is appropriate determining the sufficiency of professional oversight to authorise a cd (e g phenobarbitone), a veterinarian must have sufficient personal knowledge of the animal's health status and condition when considering further supply, they must determine that the animal’s circumstances have not changed, and that the choice of medication and treatment regime is still appropriate the required level of oversight should be determined by professional judgment, balancing the risks of the cd with the stability of the animal’s condition there are complex challenges for prescribers, in relation to issues such as legitimate medical use versus misuse, overuse, diversion, substance use disorder, and overdose phenobarbitone (phenobarbital) is an essential, lifesaving antiepileptic drug (aed) and is considered the first line of treatment this is because of its efficacy, broad coverage for multiple seizure types, ease of use, low cost, and good tolerability although phenobarbitone is considered essential, it is also listed with other barbiturates as a controlled substance because it has the potential to be abused the key question for veterinarians is what level of consultation is required to ensure the treatment is still safe and effective for the next 30 days? 1\ compulsory monthly consultation a formal consultation with the veterinarian authorising the cd is required for each 30 day authorisation this consultation establishes that the animal remains under the care of the veterinarian this consultation must be performed by the veterinarian themselves and must not be delegated it should include a review of the following factors, which will determine if a physical examination is required time since initial diagnosis/last examination the longer it has been since the animal’s last physical exam, the higher the need for a new one generally, a physical exam is compulsory at least every three to six months for stable, chronic cases, and more often for unstable or high risk cases stability of condition has the primary condition (e g seizure frequency) been consistently stable? evidence of stability for example has recent therapeutic monitoring been performed? evidence of breakthrough events or deterioration requires an immediate physical examination animal’s medical history and comorbidities any concurrent diseases or new symptoms that could affect the drug’s metabolism (e g liver disease in a cat on phenobarbitone), drug distribution, or excretion require a physical exam and potentially lab work changes in treatment plan any recent changes to the cd dose or the introduction of new concurrent medications require closer monitoring this should be done as an in person review to assess for interactions 2\ criteria for mandatory physical examination an in person physical examination should be considered necessary if any of the following apply condition category criteria triggering physical exam rationale patient status acute or unstable condition deterioration of the primary condition or new clinical signs (e g lethargy, ataxia, or weight loss) that have been reported by the owner ensures timely detection of efficacy loss or adverse reactions high risk medication/species high risk cd or species specific toxicity the specific cd has a narrow therapeutic index (like phenobarbitone), or the animal is a species known to be highly sensitive (e g cats with deficient glucuronidation pathways) mitigates higher risk of toxicity/accumulation monitoring deficits lack of recent monitoring data laboratory results (e g therapeutic drug monitoring, haematology, or biochemistry) are outdated or missing these tests are critical for safe use confirms safety and efficacy through objective data six monthly re assessment scheduled mandatory six monthly review it has been six months since the last comprehensive re assessment, which requires a full physical exam to confirm the ongoing need for the medication fulfils the professional standard for ongoing therapy aligns with the maximum period of supply for rvms in companion animals 3\ criteria for remote medical progress assessment consultation (e g phone/video review) a monthly consultation and authorisation of further supply without a physical exam may be appropriate for a limited time and only when the following criteria are met and documented 1 patient stability the animal is on a long term treatment plan, and the condition is stable and well controlled 2 low risk status the risk factors (species sensitivity, co morbidities etc) are known and currently stable and at a low level of risk 3 recent exam a thorough physical examination has been performed within the last three to six months 4 sufficient monitoring data recent laboratory work (where required for the cd) is available and confirms safety and efficacy (e g phenobarbitone levels are within the therapeutic range) 5 owner compliance and competence the owner demonstrates a high ability to monitor, observe, and comply with the treatment recommendations a remote medical progress assessment consultation must be documented as a formal part of the patient’s records, detailing the verbal confirmation of the animal’s stability and that there have been no adverse effects identified essential documentation requirements given the risks associated with the use of cds, meticulous documentation of their use is a core professional standard these standards are clearly detailed in the code of professional conduct here the patient record should include risk factors management specific risks (e g potential hepatotoxicity with phenobarbitone) and a plan to manage them, including the required monitoring data and frequency of testing justification for supply period the specific rationale for the 30 day supply (if the maximum supply is given) and why the chosen level of oversight (physical exam versus a remote review) is sufficient for the next 30 days scheduled follow up a documented and scheduled date for the next mandatory physical re examination and/or blood work owner communication documentation of informed consent from the client, including the discussion of potential species specific adverse events the ultimate decision rests with the professional judgment of the veterinarian, who must be able to back the chosen course of action successfully if there is an adverse outcome or the decision was to be scrutinised