New prescription drug regulations impact dental offices
Many new prescription drug regulations have recently taken effect, or will take effect in the near future. These regulations may impact dental offices in Ohio.
Start Talking! Consent form
This summer Gov. John Kasich signed House Bill 314 into law. The law requires prescribers to obtain a statutorily defined informed consent form, known as the “Start Talking!” form from a parent, guardian or other authorized adult prior to prescribing a minor a controlled substance that contains an opioid. A minor is defined as a person under the age of 18 who is not emancipated.
Once completed, this form must be kept as a permanent part of the medical or dental record. The provisions of the new law went into effect Sept. 17.
For complete details on the new law and to download a copy of the Start Talking! form, please click here.
Hydrocodone combination products reclassification
The Drug Enforcement Administration (DEA) recently reclassified hydrocodone combination products (HCPs) as Schedule II substances. Schedule II substances have tighter restrictions. This change went into effect Oct. 6.
Schedule II prescriptions can only be written for a single dose supply, and dentists who are not registered as Schedule II prescribers will need to register with the DEA in order to prescribe HCPs.
Properly authorized prescriptions written before Oct. 6 may be refilled until April 8, 2015. Under the new classification, prescribers will not be able to call or fax prescriptions or refills to any pharmacy unless it is an emergency, in which case they can do so for a 72 hour supply. E-prescriptions are permissible as long as the software used meets DEA requirements.
A new law will require prescribers who prescribe or personally furnish opioid analgesics or benzodiazepines to register for the Ohio Automated Rx Reporting System (OARRS) database as a condition of licensure renewal.
OARRS collects detailed prescription information and is utilized by law enforcement entities to monitor the misuse and diversion of controlled substances. OARRS may be accessed for free by prescribers to obtain information on controlled substances dispensed to patients of record. The registration requirement goes into effect Jan. 1, 2015.
The law also requires prescribers to check OARRS before furnishing or issuing a prescription for a supply of an opioid analgesic or benzodiazepine for a period longer than seven days. This new requirement goes into effect beginning April 1, 2015.
Dentists who have not already created an OARRS account should consider registering as soon as possible and should strongly consider how much pain medication to prescribe to patients.
To access OARRS, dentists must create an account by visiting www.ohiopmp.gov and completing the free registration process.
Controlled substances inventory
Prescribers and terminal distributors of dangerous drugs will be required to take a new inventory of all stocks of controlled substances on hand every year.
The new Pharmacy Board rule takes effect Jan. 1, 2015. Currently, prescribers and terminal distributors of dangerous drugs are required to take inventory every two years.
Tramadol and products containing tramadol are now classified as Schedule IV controlled substances. This new classification went into effect Aug. 18.
All tramadol products must be part of the controlled substance inventory. Prescribers without a DEA registration will not be able to issue prescriptions or personally furnish tramadol or tramadol containing products.
In order to submit a prescription for tramadol electronically, the prescriber and the receiving pharmacy must both be using an electronic prescription transmission system that meets the DEA’s requirements.
For more information, visit http://pharmacy.ohio.gov/deatramadol.