5 Dec 2023
Peter Kukadia considers how professionals should proceed in the wake of these changes.
The recent decision by the RCVS to permit the remote prescribing of prescription-only veterinary medicines (legal category, POM-V) has caused a huge tectonic shift on the ground.
Veterinary surgeons, using their clinical judgement, now have the flexibility to prescribe POM-V drugs to patients without an initial physical examination, subject to the guidance set out in the RCVS Code of Professional Conduct for Veterinary Surgeons.
Dermatological disease can have an adverse impact on the quality of life of the patient and its owner. With rising costs, the pet-owning public will not hesitate to shop around to find a good deal for their pet’s treatment, and the reliance on obtaining advice and written prescriptions from an interactive virtual clinic has the potential to become the “new normal” interaction between pet owner and vet.
From a remote dermatology perspective, the practitioner faces various challenges. The following case study serves to highlight the complexities of making the right clinical judgement remotely without adversely impacting the welfare of the patient. The patient is registered at a small animal practice. For pets on long-term medication, the practice policy is to physically examine them every six months, with a remote consultation midway at three months to address any concerns the owner might have in the interim.
Lily is a four-year-old, 28kg, female, neutered English bulldog with a history of chronic atopic dermatitis. She was last examined three months ago, and her owner has requested a repeat course of corticosteroids, as this has helped control her daily pruritus. Her pruritus score at the last physical examination was recorded to be 2 out of 10 (pruritus scale adapted from Rybnícek et al, 2009). This has been maintained with oral prednisolone at a dosage of 10mg every other day (approximately 0.3mg/kg/day).
The pruritus prior to the induction of corticosteroid therapy measured 7 out of 10 on the scale.
Lily’s owners are very anxious, as they state that in the past three weeks that they noticed she was “scratching, putting her head to the side more and occasionally letting out a whimper”, and had a smell of “extra-mature cheddar” coming from her ears. A similar flare-up of signs five months ago resolved with a course of ear drops and oral paracetamol.
The owners are keen for Lily to be managed remotely, as they understood at the last visit that they would not need to bring her into the clinic for six months after the in-clinic consultation. They will be waiting for reception to ring them to arrange collection of any medications.
They have also emailed an image of Lily’s affected ear (Figure 1) for consideration as part of the clinical assessment.
By current definition at the time of writing (October 2023), the patient is deemed to be under your care; considering both the clinical factors and client expectations, which of the following options would you discuss with them to help manage this case?
Propose a change to Lily’s medication by offering to provide a written prescription for oclacitinib at a dose rate of 0.4mg/kg/day to 0.6mg/kg/day twice daily for 14 days, and to instruct the owner to clean the ears three times weekly with a commercial propylene glycol and isopropyl alcohol containing ear cleaner.
Provide a written prescription for a triamcinolone and salicylic acid ear drop preparation coupled with an increase in the dose of prednisolone to 0.5mg/kg/day for seven days (equating to a daily total dose of approximately 15mg), and then decreasing to the maintenance dose of approximately 0.3mg/kg/day thereafter until another flare-up.
Provide written prescriptions for gabapentin capsules (300mg) and a miconazole, polymyxin B and prednisolone topical ear drop suspension as per the owner’s request, as these worked previously (owner wanting them to be put on repeats).
Clinical decision-making involves consideration of patient, disease and client factors. In parallel, veterinary surgeons are obliged to comply with the relevant legislation and regulatory guidance as set out in the Veterinary Medicines Regulations 2013 and RCVS Code of Professional Conduct for Veterinary Surgeons, respectively.
The remote treatment options from the previous list all propose the prescription of a POM-V drug as part of the pet’s therapeutic plan. Recently published guidance from the RCVS on the definition of “under care” and remote prescribing permits the veterinary surgeon to prescribe a POM-V drug without a physical examination, on the proviso that their clinical assessment has given enough information to diagnose and prescribe safely and effectively (RCVS, 2023).
More specifically, the guidance suggests some factors for the clinician to consider before prescribing POM-V drugs, with paragraph 4.15 of the code of professional conduct indicating that “the more complex the case, the more likely a physical examination will be necessary”.
The potential complexity of otitis is summarised in Table 1. The PSPP system (considering primary and secondary cases, and perpetuating and predisposing factors of ear disease) is used to systematically consider all the possible factors that might be involved in the pathogenesis of a patient’s ear disease.
Table 1. The pathogenesis of otitis is multifactorial |
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---|---|---|---|
Primary | Secondary | Predisposing | Perpetuating |
|
Bacterial infection
Yeasts
|
|
|
Primary causes: factors that cause initial inflammation of the ear. Secondary causes: infections that occur secondarily. Predisposing factors: factors that increase susceptibility to clinical otitis in the presence of the primary cause. Perpetuating factors: factors that occur due to the otitis and failure to address these will cause the otitis to persist/reoccur. Collectively, this is referred to as the PSPP system. | |||
Note: not all factors will be present in every patient, and this is not a comprehensive list. |
The primary factor is canine atopic dermatitis, for which the patient is receiving treatment with systemic corticosteroid therapy. The secondary (infection), predisposing (stenosis) and perpetuating (hyperplasia, calcification and potential otitis media) factors also need due consideration, as failure to identify and address these will likely lead to treatment failure, and progression of the pathological changes with adverse effects on patient welfare.
Given the multifactorial nature of otitis, it is the author’s opinion that patients presenting remotely with ear disease should be offered an in-clinic appointment to obtain a relevant history, perform a physical examination including otoscopy, and to collect cytology specimens.
The choice of which POM-V medication to prescribe remotely is a matter of judgement for the veterinary surgeon. Paragraph 4.14b of the RCVS guidance is particularly pertinent to this scenario, where it is suggested that when the practitioner is deciding whether a physical examination is required, “the nature of the medication prescribed, including any possible risks and side effects” needs to be considered.
In this patient’s case, one outcome from the remote consultation to control her flare of atopic dermatitis offers to switch her systemic treatment from prednisolone to oclacitinib. Oclacitinib is an agent indicated for the treatment of pruritus associated with allergic dermatitis and the clinical manifestations of atopic dermatitis in dogs. Briefly, it is a selective Janus kinase 1 (JAK-1) inhibitor that targets the signalling of cytokines such as interleukin (IL)-2, IL-4 and IL-31 (among others), which consequently brings about a reduction in pruritus and inflammation (Gonzales et al, 2014).
Oclacitinib has a rapid onset of action within 24 hours (Cosgrove et al, 2013a) with its anti-inflammatory effects found to be comparable to prednisolone (Gadeyne et al, 2014), lokivetmab (Marsella et al, 2020) and ciclosporin (Little et al, 2015) at days 14, 28 and 56 post-commencement of therapy, respectively.
Alongside their therapeutic benefits, immuno-modulators can be associated with collateral adverse effects, with the datasheets of ciclosporin and oclacitinib recommending caution in patients with a history of malignancy. Table 2 summarises some of the adverse effects that have been reported with these therapies, ranging from very common to rare (taken from Noah, 2023).
Table 2. Some reported adverse effects of the licensed immunomodulatory therapies. Data compiled from the NOAH website, 2023 |
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---|---|---|---|---|
Body systems agent | Clinical pathology | Gastrointestinal | Dermatological | Other |
Oclacitinib | NSF on haematology |
Vomiting (C) |
Otitis (C) |
Cystitis (C) |
Ciclosporin | NSF on haematology | Vomiting (C) Diarrhoea (C) |
Papillomatous lesions (U) |
Gingival hyperplasia (U) |
Ectoparasites | NSF | Vomiting (R) | NSF |
Lethargy |
Key: NSF: no significant findings; (C): common – more than 1, but less than 10 animals in 100 animals treated; (U): uncommon – more than 1, but less than 10 animals in 1,000 animals treated; (R): Rare – more than 1, but less than 10 animals in 10,000 animals treated. *Association is different from causation (see Marsella et al, 2023). | ||||
Note: this is not a comprehensive list of adverse effects; the reader is asked to consult the relevant datasheets and manufacturer for further information. The decision to prescribe these agents without a physical examination lies with the individual veterinary surgeon. |
In view of the advice given on the datasheets, it is the author’s view that an in-clinic, thorough physical examination be performed prior to the prescription of any immunomodulatory drug. This can help to identify any patient comorbidity or contraindications to their use, and provide sufficient clinical information to the client for them to make an informed choice about treatment.
Furthermore, in an increasingly litigious society, it would be rational for the veterinary surgeon to practice due diligence before authorising the remote prescription and dispensing of such agents should the patient require them in the future.
Cleaning is an essential step to successfully managing ear disease and owners should be trained on this accordingly. It helps to clear ceruminal and purulent discharge, toxins, microorganisms and cellular debris that have accumulated in the ear canal because of the underlying disease processes.
Some agents have antiseptic properties, with isopropyl alcohol and parachlorometaxylenol having been demonstrated to have anti-Malassezia (Mason et al, 2013) and anti-staphylococcal activity (Swinney et al, 2008), respectively.
These benefits, however, are offset by the presence of propylene glycol in some cleaners, a ceruminosolvent which has caused hearing loss and destructive changes when instilled into the middle ear (Morizono et al, 1980). Considering the risks, the clinician should be confident that the tympanic membrane is intact before including a cleaner into the treatment plan.
The risk of ototoxicity in this case is potentially augmented by offering to remotely prescribe topical POM-V ear drops without having assessed the tympanic membrane. Drugs such as gentamicin and polymyxin have the potential to be ototoxic (McKeever and Torres, 1997), with the product datasheets of their respective licensed preparations stating that they should not be used where a perforated or absent tympanic membrane is found (Noah, 2023).
Moreover, in its recent update of the under care guidance, the RCVS stated that in all but exceptional circumstances, a physical examination is now required where a veterinary surgeon prescribes antibiotics, antifungals, antiparasitics or antivirals for an individual animal (RCVS, 2023), with the former two drug classes being incorporated in all 10 of the ear drop preparations authorised in the UK to treat otitis externa.
Favourably, however, a face-to-face visit is an opportunity for the clinician to discuss the complexities of the condition with the owners, assess the patient and perform diagnostic tests (such as in-house cytology) with a view to practising good antimicrobial stewardship.
Triamcinolone, a moderately potent steroid, and salicylic acid, a keratolytic agent in a combined ear drop preparation is authorised for the treatment of otitis externa and seborrhoeic dermatitis of the auricle.
Nevertheless, they are not permitted to be used in the presence of a tympanic membrane rupture, and so an examination prior to prescribing is advised.
Otitis can be excruciatingly painful in the dog and cat, with the patient in this scenario displaying a head tilt to the side with occasional vocalisation.
In the author’s practice, systemic corticosteroids are the mainstay for initially managing allergic, painful otitis, as patients cannot often tolerate a detailed aural examination at their first visit. The use of NSAIDs would be contraindicated in this scenario, and the provision of appropriate analgesia to patients can, therefore, become challenging.
For patients on steroids, the 2022 WSAVA guidelines for the recognition, assessment and treatment of pain recommends the use of paracetamol (with or without codeine) for dogs only; for those chronic cases that may have a neuropathic component to their pain, the authors suggest gabapentin as an alternative (Monteiro et al, 2023).
The clinician should exercise caution when proposing to prescribe a controlled drug (CD) remotely due to the strict legal and regulatory prescribing requirements in place for these medicines.
The reader is reminded of paragraph 4.18 in the RCVS code of conduct, which states: “(…)when prescribing a controlled drug to an animal, veterinary surgeons should in the first instance carry out a physical examination in all but exceptional circumstances and be prepared to justify their decision where no physical examination has taken place”.
In this case, the client would be advised to schedule an appointment for an in-clinic physical examination. The only licensed CD preparation that is not subject to strict storage and dispensing requirements is Pardale-V (Dechra, UK), and this would be a suitable alternative if judged appropriate by the veterinary surgeon.
Dermatological diseases can have a multifactorial aetiology and, as such, the more complex the case, the more likely a physical examination is necessary.
Furthermore, Lily’s case highlights that although the possibility exists to remotely prescribe certain medications without an initial physical examination, patient, disease and drug factors need to be considered in the decision-making process. The clinician is also obliged to comply with the relevant legal and regulatory guidance as set out in the Veterinary Medicines Regulations 2013 and RCVS Code of Professional Conduct for Veterinary Surgeons.
Use of some of the drugs in this article is under the veterinary medicine cascade.
The author wishes to thank Catriona MacKinnon for her review and constructive comments.