A message from the 2019-2020 CFDDA President,
Myriad of Topics
I hope our newsletter finds everyone in good spirits and ready for the New Year. As of December Marlinda, myself, and Dr. Drew Johnson, CFDDA Program Chair, completed our affiliate visits. From the Dental Society of Greater Orlando to our most recent visit in Volusia County, we have noted in our “Hot Topics” section of the PowerPoint presentation a number of new rules and regulations which affect how we practice dentistry. Honestly, the myriad of topics were a challenge to sort out. So here we go.
As mentioned in the last message, the Restorative Function Dental Auxiliary Rule allows dental assistants and hygienists to perform restorative procedures under direct supervision. It is important to note these individuals must complete mandatory training at an accredited dental or hygiene program. We have not been informed of any program which is presently up and running. At the Alachua affiliate meeting in November, Dr. Isabel Garcia, Dean of UFCD, stated the program is being developed. No timeline was given.
I just received a letter from the Brevard County Commissioners and the Natural Resources Management Department. I suspect this letter by now has been sent to all practitioners in the state regarding a Federal Rule adopted on August 21 of this year. This rule is highlighted in the October 22, 2019 edition of Today’s FDA, “Now You Know” segment. The EPA has given its Final Rule for Hazardous Waste Pharmaceuticals (HWP). We have posted the article on the CFDDA website, *www.cfdda.org, as a reference. There are links for contacting the Florida Dental Association if you need more information or have questions. Please note how partially used anesthetic carpules and expired medication no longer qualify as Biohazardous Waste. Rather, they fall into the category of HWP which requires a different mode of disposal separate from Biohazardous Waste. The FDA’s segment also lists other classes of pharmaceuticals which are relevant to dentistry and require HWP disposal. First and foremost, the law addresses where not to dispose of pharmaceuticals, i.e. the toilet or drain. We will include the Brevard County letter on the website as it has numerous hyperlinks to government sites tangential to the Rule.
As I mentioned in my PowerPoint presentation, an important reason to belong to organized dentistry and support our FDAPAC is that health care is one of the most regulated industries. The EPA is not the only federal entity which is regulating our profession. The Drug Enforcement Administration (DEA) may make visits to our offices to inspect/audit registered controlled substance storage locations. Controlled substances include any Rx prescription item with an NDC code (National Drug Code). This includes high fluoride toothpaste such as Prevident 5000, local anesthetics, and chlorohexidine rinse. The DEA is interested in assuring pharmaceuticals have a known origin and traceable history to our offices. Drugs bought on the internet may not be traceable to its manufacturer or may be counterfeit. Transaction documents are a provision which our dental suppliers have had to conform to. We have to, upon request from an inspector, know how to access the transaction history documents for our prescription pharmaceuticals. Our dental suppliers Patterson, Henry Schein, Benco, etc., have had to partner with a third party (Tracelink for Patterson) to provide this service to us as an end user of the drug. If you were to look at the side of a box of Clinpro 5000 toothpaste you will notice a Global Trade Identification Number (GTIN). This number allows for tracking of the controlled substance from the manufacturer to wholesaler to us. As the name indicates, on a global scale.
Lastly, we will move from the federal level and get closer to home. This topic has been on the “books” since 2007 and is a state mandated law. A Health Care Clinic Establishment (HCCE) permit which costs $255.00 every two years allows for a corporation with numerous dentists to purchase scheduled pharmaceuticals under its name so each provider does not have to purchase drugs individually under his or her own license. Casey Stoutamire, FDA Director of Third Party Payers & Professional Affairs, sent me a background statement which helped to clarify why it is necessary for a solo practitioner to have this permit. Most solo practitioners are incorporated for tax and liability purposes. Essentially, if we use our corporation checks to pay for the drugs we use in the office (local anesthetic), then the corporation owns the drugs and the permit is required. Again, check the CFDDA website for a copy of the memorandum from Casey which will explain the rule in more detail.
Please remember to open your emails from the Florida Dental Association as topics such as these are often presented and discussed. As these rules became talking points in the affiliate presentations some were aware of the implications, but many were not. The DEA regulations are especially onerous as they come with stiff penalties for noncompliance. Use the FDA as a resource in navigating these waters. On that thought, we are nearing 60 rooms booked for our cruise. I would love to celebrate our profession with the best members of the FDA from Central District. Remember whether it is the cruise or next year’s annual meeting in Palm Coast, your dues and the support of our sponsors offset costs to where we do not charge for the CE portion of the meeting. It is a great CFDDA membership benefit that not all the other components offer to their members. Take advantage of it.
*All documents mentioned in the above article are located towards the bottom of the homepage of the CFDDA website.