HOW TO SURVIVE A DEA INSPECTION SERIES: PRESCRIBING BUPRENORPHINE FOR OPIOID DEPENDENCY”©
(DISCLAIMER: PharmaDiversion LLC™ does not act or speak on behalf of DEA)
Every pharmacy has filled at least one prescription for Suboxone written by a prescriber for opioid dependency. According to the Substance Abuse & Mental Health Services Administration (“SAMHSA”) there are 30,215 physicians registered in the United States to prescribe Buprenorphine for opioid dependency. Of those, there are 1,907 physicians in the State of New York, 737 registered in the State of New Jersey, 958 Physicians in the State of Pennsylvania, 334 physicians in the State of Connecticut and 111 physicians in the State of Rhode Island. You can go to their website www.samhsa.gov to learn more on the use of Buprenorphine for opioid dependency.
With that in mind, SAMHSA also provides the accreditation for all Opioid Treatment Plan which are programs to dispensed Methadone and Buprenorphine as part of a treatment plan for patients addicted to opioids and could be treated with such controlled substances. These programs will most likely dispense the medication to the patient on a daily basis.
The Drug Enforcement Administration (“DEA”) has the jurisdiction to allow a physician to prescribe a controlled substance as part of a patient’s treatment plan. Once a physician is granted a state license to practice medicine and in some states requiring a Controlled Drug Stance registration, the physician will apply to DEA through their Registration Section of the Office of Diversion Control (“DEA Diversion”) to obtain a DEA registration.
The ability to prescribe Buprenorphine begins with an application to SAMHSA Center for Substance Abuse Treatment (“CSAT”) who will contact DEA Diversion to see if there is no objections for a DEA registered physician to receive a waiver to be a prescriber of Buprenorphine under the Drug Addiction Treatment Act of 2000 (“DATA”). You often heard that a physician is a DATA WAIVE PHYSICIAN (“DWP”) which permits him/her to prescribed controlled substances approved by the Food & Drug Administration (“FDA”) for opioid dependent patients in their medical office. As of now, Buprenorphine is permitted to be used for such purpose but most often Suboxone is the most prescribed because of its ability to prevent such patients to used Suboxone and an opioid at the same time because of the Naloxone which prevent misuse.
During a DEA or prescription benefit manager (“PBM”) inspection, the mistakes most often made by a pharmacist when filling a Suboxone prescription is the failure of the prescriber of such prescription to include the address of the patient and the special DEA number given to such prescriber. In most cases, the pharmacist should contact the prescriber and obtain permission to fill in such information. The label placed by a pharmacist on the back of a prescription is a SECONDARY RECORD and the primary is what is written on the front of the prescription. It is important for the pharmacist to go to the DEA Diversion website www.deadiversion.usdoj.gov and look up the registration of the prescriber to assure the pharmacist that the prescriber has the ability to write such prescription.
In the DEA Diversion website if you search the physician’s profile you will see next to business activity of the physician a DWP/30 or DWP/100. This means that a prescriber can have no more than 30 or no more than 100 active patients at the same time. Unless you ask the physician, you will never know that information, unless you are filling prescriptions for an excess number of patients for that physician. Remember, that the identification number is the same as the DEA registration. For example, if the DEA number is AB1234567 than the DWP number is XB1234567 and both numbers must be listed on the prescription. Generally the X DEA number appears under the regular DEA number. If you want to read the DEA regulation, go to the DEA Diversion website and look under the “Resources” tab located at the bottom. You want to read Title 21, Code of Federal Regulations 1301.28 and 1306.05 (b) along with the federal law under the Controlled Substances Act Section 823 (g) (2) (G).
One of the areas of concern is when a physician write a prescription for Suboxone for 30 day supply along with a prescription for a benzodiazepine such as Alprazolam. DEA may look at and ask you why a physician would write such combination. While I am not telling you how to fill a prescription but what I am saying is to be careful when filling prescriptions for Suboxone. The other issue you need to carefully review is that such Suboxone prescription may have a value to the illicit market. So you need to know your patients and do an “I-Stop” or PMM patient profile. The last thing you want is to have DEA ask you why you are filling a Suboxone prescription while the patient is being prescribed an opioid by another practitioner. Such example will cause a pharmacy and the pharmacist heart-burn and may lead to an administrative or civil action by the DEA Diversion Office. As I always mention in CE for pharmacists, this “willful blindness” or “deliberate ignorance” is what DEA needs to prove to take your pharmacy registration.
If DEA walks into your pharmacy with issues for Suboxone prescriptions, in all events they will look at your records required by DEA and the security of your pharmacy. If they bring members of the state regulatory entity such as the New York Board of Pharmacy then expect that they too will look at records especially HIPAA compliance and methods of billing prescriptions. Be safe.