For Part II of this newsletter series we are going to be covering the upcoming changes in the CA Board of Pharmacy Regulations that will have the biggest impact on your veterinary practice: Office Use Compounds. As many of you may have seen over the summer CVMA put out an article in which the Board of Pharmacy stated that they did not intend the existing Office Use regulations or the 72 hour supply requirements to apply to Veterinary Practice. The newly approved regulations that go into effect on January 1, 2017 do directly apply to Office Use supply and dispensing of compounds from Office stock for vets. Below is the exact language from the regulations:
From § 1735.2 in Article 4.5 of Division 17 of Title 16 of the California Code of Regulations:
(c) a “reasonable quantity” that may be furnished to a prescriber for office use by the prescriber as authorized by Business and Professions Code section 4052, subdivision (a)(1), means that amount of compounded drug preparation that:
(1) Is ordered by the prescriber or the prescriber’s agents using a purchase order or other documentation received by the pharmacy prior to furnishing that lists the number of patients seen or to be seen in the prescribers office for whom the drug is needed or anticipated and the quantity for each patient that is sufficient for office administration; and
(2) Is delivered to the prescriber’s office and signed for by the prescriber or the prescriber’s agent; and
(3) Is sufficient for administration or applications to the patients solely in the prescriber’s office, or for furnishing of not more than a 120- hour supply for veterinary medical practices, solely to the prescriber’s own patients seen as part of regular treatment in the prescriber’s office, as fairly estimated by the prescriber and documented on the purchase order or other documentation submitted to the pharmacy prior to furnishing; and
(4) That the pharmacist has a credible basis for concluding it is a reasonable quantity for office use considering the intended use of the compounded medication and the nature of the prescriber’s practice
So what does this mean to you? The Board of Pharmacy is clearly indicating that they understand the importance of Office Use compounds in veterinary practice and has explicitly endorsed the compounding of necessary medications for use in clinic. Additionally, they clarified the amount of medication that may be legally dispensed to a patient from your clinic stock of compounded meds as a 5-day supply; perfect for sending home the standard Metronidazole treatment.
They have also placed some burdensome requirement s on the ordering of Office Use compounds to prevent the illegal dispensing of compounded medications ordered under the guise of “Office Use”. When an order is placed for compounded Office Stock, you will be required to indicate how many patients you anticipate needing the compound for and you will also be required to indicate how much you anticipate using per patient; both for in clinic administration and for dispensing up to a 120 hour supply. As the ordering clinic, you will need to do some calculations to determine your usage of the compound and as the supplier we are going to have to make sure that the numbers you provide us make sense based on the quantity ordered.
To help ease the burden of these new requirements we will be developing 2 tools to help simplify the ordering process. We are currently working on an “Office Use Formulary”. Essentially a list of the most commonly ordered compounds for Office Use, in the most common sizes ordered, with the appropriate estimated usage per patient to help you determine the correct amount to order and your anticipated usage. We will also be developing a new Office Use ordering form that will have all of the necessary fields. When ordering you will be able to cross reference the Formulary to determine the appropriate quantity to order and the appropriate usage. Anything ordered for Office Use that is not on the Formulary, you will need to determine the amounts yourself as they will still be required. We will make both these tools available over the next month so you will have time to implement them into your ordering process prior to January 1st. We will post the forms to our website and we will also be updating our online ordering form to reflect these changes.
We understand this will be a significant change in the ordering process and understand there will likely be an adjustment period as we all get used to the new system. Our pharmacists are always available to help you through the process should you have any questions.
For Part III of the newsletter series we will be discussing the new regulations that are having the biggest impact on our practice; the compounding and handling of drugs considered hazardous. While these changes may only minimally impact your practice we feel it’s important that you know and understand the importance of these new regs and the steps that we are taking to comply with them both for the benefit of the patient and for the protection of our compounding personnel. Stay tuned for that update sometime in early December!