2018 June - Compounded pharmaceuticals
With some restrictions under the Poisons and Therapeutic Goods Act 1966 and the Stock Medicines Act 1989 (most notably in relation to food producing species), the supply options for a veterinarian in NSW include a registered product for that animal species, a registered product for use in another animal species or humans or an unregistered product compounded by either a compounding pharmacy or the veterinarian.
Veterinarians have indicated that compounded medications provide a number of potential benefits for veterinarians, animal owners and animal welfare
Compounded medications may:
1. Increase the range of available therapeutic agents to veterinarians
2. Allow more precise dosing of some animals
3. Improve animal owner compliance
There are a few important points to consider
Under the Veterinary Practice Regulation 2013 (sch 2) (Veterinary practitioners code of professional conduct) (Code) when considering the use of compounded pharmaceuticals:
1. You may supply a compounded pharmaceutical for an animal that you have physically examined or have under your direct care and only in respect of that animal (clause 20).
2. You must carry out procedures according to current standards and you must base professional decisions on evidence-based science or well-recognised current knowledge or both (clause 4). The Board is of the opinion that the current standards of veterinary practice require that compounded medications are indicated when a suitable registered veterinary product is not available.
3. You must ensure you obtain informed consent from the person responsible for the care of the animal before providing veterinary services to the animal and this includes the likely extent and outcome of the veterinary services (clauses 7 and 16). It is important to ensure the client is aware of the likely risks and benefits surrounding the use of a compounded pharmaceutical.
4. You must obey any code or rule of an animal sporting organisation when working within that industry (clause 14). It is vital to ensure that the compounded product does not contain any substances prohibited under the rules of the relevant animal sporting organisation.
Here are some frequently asked questions received by the Board regarding the use of compounded pharmaceuticals
1. Is the veterinarian able to supply the compounded medication to the client directly rather than the medication going straight to the client from the compounding pharmacy?
Yes. There is a provision for indirect dispensing to the client by the compounding pharmacy.So, if it is more convenient for your client the compounding pharmacy may dispense the medication to the client via your veterinary practice.However, the compounding pharmacy must be able to demonstrate a direct pharmacist-client relationship.
Please note that the veterinarian is not dispensing the compounded medication in this circumstance. The compounding pharmacy is a pharmacy and not a wholesaler so this is different to you supplying a product you have purchased from a wholesaler.
2. Can the veterinarian put a dispensing fee on the price of the compounded medication or mark up the compounded medication when supplying to the client?
No. Unlike medication received from a wholesaler the veterinarian is not dispensing the product. You cannot treat medication from the compounding pharmacy the same as medication from a wholesaler. The veterinarian is best able to deal with the costs and time involved with supplying a compounded pharmaceutical through a prescription fee. If the veterinarian is supplying the medication indirectly then a freight fee may also be applicable.
3. Can the veterinarian provide an additional label to the compounded medication (so that it does not obscure the pharmacy label such as on the outer package)?
No. It is illegal in NSW for a veterinarian to place an additional label on prescription medicine dispensed by a pharmacy (this includes a compounded product).
4. Can the veterinarian provide additional written instructions to the client to augment the information provided by the pharmacy generated label?
Yes. This may also be a good place to remind the client of the potential time delays in providing further supply of medication as this is medication specifically compounded for their pet and therefore there are no stocks of the medication kept on the premises.
5. If a client has a question or problem with a compounded medication the label will typically provide contact details for the compounding pharmacy but it might be equally important to discuss an adverse event or other problem with the veterinarian as well. How can this issue be addressed?
Compounding pharmacists are able to discuss the problem with the client and provide either specific advice about the medication or refer the client to the veterinarian as the veterinarian’s contact details are linked to the label and prescription.Alternatively, as there is a direct veterinarian-client relationship, the client may choose to contact the veterinarian initially and the veterinarian can attempt to resolve the issue or refer the client to the pharmacist as appropriate.
6. The compounding pharmacy may need more than 24 hours to fill the prescription. If the client is late requesting a repeat there is a gap in medicating the animal. Is the vet able to prescribe and store any quantity of compounded medications?
No. Compounded medications are prepared for an individual animal by the compounding pharmacy and therefore they cannot be stored in the practice or treated as if they were provided by a wholesaler. Compounded medications provide a number of benefits to clients but this is one potential disadvantage that you should discuss with the client to try to avoid periods where the animal is not medicated.
7. Is the veterinarian able to titrate the dose of the compounded medication? For example, can the directions for use on the prescription state: “Give 3 mL twice daily or as directed by your veterinarian”?
Yes. For compounded products, the veterinarian is responsible for providing instructions to the pharmacist for compounding of the products and the required label directions for use. You can also provide additional written information to assist your client.
Please note however that the compounding pharmacist may not be able to guarantee the accuracy of dosing beyond a certain point hence it is best to discuss the individual needs of your patient with the compounding pharmacist.
8. Does the veterinarian have to provide a prescription or can the veterinarian order for in-clinic use?
A compounding pharmacist may only commence compounding for an animal medication on the instruction or a prescription from a veterinarian. The instructions do not have to be in writing, but it is best practice to provide instructions in writing where possible.
In order for the compounding pharmacist to dispense the compounded product, a prescription must be issued that identifies the owner, the specific animal and quantity of compounded product sufficient to treat the animal.
The veterinarian cannot order compounded veterinary pharmaceutical products for general use in other animals at a later date. There is no provision allowing for the general preparation and storage of compounded pharmaceutical products.
The Pharmacy Council of NSW has recently received a number of complaints in relation to the authenticity of raw materials used in compounded preparations. Further information and fact sheets are available from the Pharmacy Council of NSW website.