Issue 51 - Use of Compounded Medications
The Board has released a new guideline on the use of compounded medications. To assist with understanding this guideline we have also reviewed our previous frequently asked questions on this topic.
So, here are some answers to 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 cost of 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 medication).
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 to meet the Board's requirement that compounded medication only be prepared and supplied for the treatment of a specific animal, the compounding pharmacist should not dispense the compounded product until a prescription has been issued that identifies the owner, the specific animal and quantity of compounded product sufficient to treat the animal.
9. What about emergency supply under the Poisons and Therapeutic Goods Regulation 2008 (cl 46)?
The Board’s advice is that the Poisons and Therapeutic Goods Regulation 2008 (cl 46) is a means by which a prescription-only drug can legally be supplied to a health practitioner without an actual prescription (identifying the patient, dosage etc.) in order that the drug is on hand should it be required for emergency treatment. Its operation is limited to ‘emergency use’ and for example would enable doctors to store a small quantity of drugs used to resuscitate patients who have a cardiac arrest.
Compounded medications are not subject to the same efficacy, safety, and quality assurance testing of registered medications and hence the potential for harm to animals and animal carers is greater when compounded medications are prescribed. Accordingly, in the veterinary context, compounded medications should be limited to individual doses for specific patients.
It is also important to note that the provision of a compounded medication for general use in animals for possible future emergency treatment would be in breach of Pharmacy Board guidelines1 which state:
Compounding veterinary pharmaceutical products containing scheduled or unscheduled medicines for individual animal patients may be carried out by a pharmacist, provided that instructions have been received from a veterinary practitioner as outlined in the Agricultural and Veterinary Chemicals Code (AgVet Code).
The quantity of compounded medicine to be supplied should be a single unit of issue for the treatment of a particular patient. For prescribed medicines, if the quantity is not specified by the prescriber, this must be confirmed with the prescriber.
Accordingly, the Board is of the opinion that veterinarians should not order compounded veterinary pharmaceutical products for general use in animals at a later date.
1. Pharmacy Board of Australia 2015, Guidelines on Compounding of Medicines, Updated content issued August 2017, Pharmacy Board of Australia