Pharmacist FAQsFrequently Asked Questions for Pharmacists on Controlled Substances/Controlled Substance Reporting Act
Q: How do I access the DEA's Controlled Substance Ordering System (CSOS)? A: https://www.deaecom.gov/csosmain.html.
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Q: How should a pharmacy dispose of drugs, both non-controlled medications & controlled substances? A: The NCBOP Drug Disposal Form can be found by logging into the facility portal. The Drug Disposal Form Tab is located at the bottom of the facility page.
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Q: May a pharmacy transfer an “on file” prescription for a controlled substance that the pharmacy never dispensed? A: Pharmacists continue to call Board staff with understandable confusion on whether and how “on file” controlled substance prescriptions that were never filled may be transferred. In April 2017, word began swirling that DEA viewed transfers of “on file” controlled substances as not allowed. On July 7, 2017, Loren Miller, Associate Section Chief, Liaison and Policy Section, Diversion Control Division, Drug Enforcement Administration sent an email to Carmen Catizone, Executive Director of the National Association of Boards of Pharmacy, setting forth DEA’s view on the matter. In that email (found here -- http://www.ncbop.org/PDF/LMillerDEAGuidanceTransferofOnFileCSPrescriptions.pdf), Mr. Miller states the view that 21 CFR 1306.25 allows a pharmacy, “once it has filled an original prescription for a controlled substance in Schedule III-V,” to “transfer the original prescription information to another DEA registered pharmacy for the purposes of allowing that second pharmacy to then dispense any remaining valid refills . . . .” Mr. Miller further stated that “an allowance currently does not exist for the forwarding of an unfilled prescription from one DEA registered retail pharmacy so that it may be filled at another DEA registered pharmacy.” Mr. Miller then stated that, based on “the preamble” of an “interim final rule,” it is DEA’s “policy” that an electronic prescription for a controlled substance of any schedule may be “forwarded from one DEA registered retail pharmacy to another DEA registered retail pharmacy” even if that prescription had not been filled. To say that DEA’s positions in this matter create a mess is a gross understatement. First, while Mr. Miller’s reading of 21 CFR 1306.25 is textually plausible, it represents a departure from decades of standard pharmacy practice and there has been no suggestion from DEA or anyone else that the standard practice of transferring “on file” but unfilled (as opposed to once-filled) controlled substance prescriptions has caused or materially contributed to controlled substance abuse or misuse. Second, neither Mr. Miller’s email nor any language in the preamble he references contains so much as a hint as to what an appropriate mechanism for “forwarding” (and documenting the forwarding of) an unfilled electronic controlled substance prescription would be. Third, Mr. Miller’s email does not explain why “forwarding” an unfilled electronic controlled substance prescription is substantively different than transferring an unfilled controlled substance prescription, whether electronic, verbal, or written. Fourth, DEA’s position creates not only an incentive, but a practical necessity, for patients seeking to change their pharmacy of choice to obtain duplicate controlled substance prescriptions from their caregiver. Interpretations and policies that guarantee duplicate prescriptions for controlled substances in multiple pharmacies hardly seems consistent with the Controlled Substance Act’s purpose to create a controlled, closed distribution system and minimize controlled substance abuse and misuse. All that said, however, DEA has shown no inclination to reconsider or clarify these positions. Where does that leave us? (1) Though “forwarding” of unfilled electronic controlled substance prescriptions is available by “policy,” the lack of any guidance from DEA on how a “forwarding” should occur and be documented means that most pharmacies and pharmacists are reluctant to entertain the practice. And who can blame them? (2) For unfilled verbal prescriptions for a Schedule III-V controlled substances, DEA’s position means that there is no mechanism for moving them from one pharmacy to another. (3) For unfilled paper prescriptions for a Schedule III-V controlled substances, a pharmacy could return the original to the patient to physically carry to another pharmacy. Board staff understand completely the practical problems of this approach. Some pharmacists have inquired why Board staff, the Board, or the North Carolina legislature have taken this position. As the above makes clear, none of the three are to blame. The present state of affairs is attributable solely, and entirely, to the DEA. Board staff will, of course, update pharmacists if the DEA sees reason and backs away from these positions. Until then, send your cards, letters, and calls to the DEA. ------------------------------------------------------------------------------------------ Q: Are there any exemptions to Controlled Substance Reporting System requirements regarding distribution of controlled substance samples? A: The North Carolina Controlled Substance Reporting System statute provides an express exemption for Schedule V non-narcotic, non-anorectic controlled substance samples: “A dispenser shall not be required to report instances in which a Schedule V non-narcotic, non-anorectic Schedule V controlled substance is provided directly to the ultimate user for the purpose of assessing a therapeutic response when prescribed according to indications approved by the United States Food and Drug Administration.” Pharmacies are, of course, prohibited by federal law from dispensing prescription drug samples of any sort. This reporting exemption, then, only applies in practical terms to physicians or other health care providers who are permitted by federal law to provide samples to patients. For information about storage, see below and http://www.deadiversion.usdoj.gov/faq/general.htm#sec-1. ------------------------------------------------------------------------------------------ Q: How must controlled substances maintained in a practitioner’s office (as opposed to a pharmacy) for dispensing or administration be stored? A: The federal Controlled Substances Act and regulations provide that all controlled substances maintained in a practitioner’s office (as opposed to a pharmacy) for dispensing or administration should be stored in a locked cabinet or other secure storage container with limited access by the office staff. http://www.deadiversion.usdoj.gov/faq/general.htm#sec-1
Click here to view/download our Controlled Substances reference pocket-card.
RED FLAGS WHEN DISPENSING: ANTI-DIVERSION EDUCATIONAL VIDEO Pharmacists – Increase your awareness of potential red flags when filling controlled substance prescriptions. Click here to access the video - or http://youtu.be/VrBh9X7MU2Y. The core of the video is built around three vignettes that allow the viewer to witness the interaction through the eyes and analysis of the pharmacist. Each vignette dives deep into the interaction of pharmacists and diverters as they face each other across the counter during a transaction. During this encounter the video highlights the red flags the pharmacist must recognize in order to fulfill the pharmacist’s corresponding responsibility to prevent diversion. The pharmacist identifies and clarifies the most critical warning signs of diversion about to take place. These red flags are highlighted through the pharmacist’s internal dialogue and on screen graphics. Some are self-evident, others not so clear. Often several of these warning signs are presented around a single prescription. The video reflects these realities as it illuminates 11 red flag behaviors. Watch the 12-minute video here: http://youtu.be/VrBh9X7MU2Y.
Q: What is the NC Medical Board's position on the use of opiates to treat pain? A: (Amended January 2017): The North Carolina Medical Board's policy on the use of opiates to treat pain. The revised guidelines may be found here: http://www.ncmedboard.org/resources-information/professional-resources/laws-rules-position-statements/position-statements/Policy_for_the_use_of_opiates_for_the_treatment_of_pain. Pharmacists are encouraged to familiarize themselves with the guidelines.
TUESDAY, MARCH 13, 2012 - PHOTO ID FAQ UPDATED Questions Regarding S.L. 2011-349, Photo Identification Prior to Dispensing Certain Controlled Substances The FAQ has been updated several times since January 5. All pharmacists should review the updates to questions #3, #5, #12, and new questions #11 and #20. Because this law is part of the NC CSA, the Drug Control Unit of the North Carolina Department of Health and Human Services also has administrative responsibilities for the statute. Bill Bronson, the head of that unit, has reviewed this FAQ and agrees with its content. CLICK HERE TO READ THE FAQs.
Q: Is it "legal" for a pharmacist to add a DEA number to a controlled substance prescription when the prescriber omits that information? A: Board staff has received a number of inquiries from pharmacists asking whether it is “legal” for a pharmacist to add a DEA number to a controlled substance prescription when the prescriber omits that information. These inquiries have been provoked, it appears, by a number of third-party plan auditors who have demanded recoupment based on supposedly “illegal” controlled substance prescriptions on which the pharmacist has added the prescriber’s DEA number. Assertions that the addition of a DEA number to a controlled substance by a pharmacist is “illegal” are, in a word, false. DEA’s own website states that “pharmacists are instructed to adhere to state regulations or policy” concerning changes or additions to controlled substance prescriptions (http://www.deadiversion.usdoj.gov/faq/general.htm#rx-7). Furthermore, Board Rule .2301 (21 NCAC 46.2301) specifically provides that pharmacists may retain and add a DEA number to a controlled substance prescription when the provider inadvertently leaves it off. ------------------------------------------------------------------------------------------ Q: How do I access the NC Controlled Substances Reporting System? A: The Drug Control Unit of the Department of Health and Human Services administers the NC CSRS. Information and FAQs may be accessed here: http://www.ncdhhs.gov/divisions/mhddsas/ncdcu/csrs and pharmacy personnel with questions about CSRS access should contact DHHS’ Drug Control Unit: nccsrs@dhhs.nc.gov. ------------------------------------------------------------------------------------------ Q: Are pharmacists required to hand sign and date controlled substance prescriptions? A: North Carolina Law no longer requires pharmacists to hand sign and date controlled substance prescriptions they fill. The North Carolina Controlled Substances Act required for many years that pharmacists hand sign and date all controlled substance prescriptions that they filled. The General Assembly repealed this provision – formerly located at N.C.G.S. § 90-106(h) – in August 2007 as part of a broader amendment to the recordkeeping provisions of the Pharmacy Practice Act. Accordingly, the hand signature and dating requirements no longer exist under North Carolina law. ------------------------------------------------------------------------------------------ Q: May a prescribing practitioner prescribe other medications on a prescription that already includes a Schedule II medication? A: Yes, a practitioner may prescribe other medications on the same prescription blank along with Schedule II medications. ------------------------------------------------------------------------------------------ Q: Can I fill Schedule II prescriptions bearing a "do not fill until" date? A: Yes, within limits established by DEA: Effective December 19, 2007 prescribers will be authorized to write multiple prescriptions on the same day to be filled sequentially for schedule II controlled substances. The Drug Enforcement Agency (DEA) issued the final rule on Monday, November 19 (https://www.deadiversion.usdoj.gov/fed_regs/rules/2007/fr1119.htm), which reflects APhA's recommendation to remove language that could have been interpreted to add an additional duty on health providers (including pharmacists) for schedule II prescriptions. However, the DEA chose not to defer to prescribers on the most appropriate time limitation, instead retaining the 90-day the prescription order limit in the original proposed rule. The new regulation does not affect State laws and regulations, which may be more restrictive. Specifically, the new rule amends Title 21 of the Code of Federal Regulations, Part 1306 as follows:
3. Section 1306.14 is amended by adding a new paragraph (e) to read as follows:
Link to Dispenser Reporting Manual (from NC Department of Health and Human Services Division of Mental Health, Developmental Disabilities and Substance Abuse Services Controlled Substances Reporting System) CONTROLLED SUBSTANCE REPORTING ACT Q. When will the controlled substance reporting system in North Carolina go into effect? A. The Department of Health and Human Services, which administers the act, reports that the system will go live on July 1, 2007. Electronic reports would be made monthly for the first year, then every two weeks afterward.
Q. What information must be reported under the controlled substance reporting act? A. The requirements of the act are at NCGS 90-113.70 [http://www.ncga.state.nc.us/EnactedLegislation/Statutes/PDF/ByArticle/Chapter_90/Article_5E.pdf]. Questions about the act should be directed to DHHS’ Drug Control Unit, which directly administers the CSRS: Kristen Weisberg, 919-715-2067 or John Womble, 919-715-2033. The act requires dispensers to report:
Q. Must my facility report controlled substance dispensing under the act? A. The act defines a dispenser as “a person who delivers a Schedule II through V controlled substance to an ultimate user in North Carolina, but does not include any of the following:
DHHS advises that, in determining whether a particular facility is a “dispenser”, facility personnel should ask themselves whether the dispensing will occur for administration to a patient population that is resident at, or confined within, the facility. If so, then the facility is not likely to be considered a “dispenser” for reporting purposes. If not, then the facility is likely a “dispenser” for reporting purposes. Some specific examples: Emergency Departments. Dispensing of controlled substances to emergency department patients, including the dispensing of 24-hour “send home” packs, would not trigger a reporting requirement. Hospital patients. Dispensing of controlled substances to hospital patients while receiving care at the hospital does not trigger a reporting requirement. This includes outpatient surgery. Dispensing controlled substances to a hospital patient for administration outside the hospital on an outpatient basis does trigger a reporting requirement. Long-Term Care Facility, Assisted Living Facility, Group Homes, Hospice Facility. These facilities are expressly excluded from the definition of a “dispenser” unless the facility has its own pharmacy that dispenses medications for administration outside the facility. Health Departments, Mental Health Facilities, Free Clinics. Dispensing controlled substances to outpatients of these facilities does trigger a reporting requirement. Prisons or Jails. Dispensing to inmates confined to the facility does not trigger a reporting requirement. ------------------------------------------------------------------------------- Q: How can I access the latest edition of the DEA's Practitioner's Manual? A: DEA recently released the 2006 edition of its Practitioner’s Manual: An Informational Outline of the Controlled Substances Act. Prepared by the DEA Office of Diversion Control, the manual is designed to assist practitioners (physicians, dentists, veterinarians, and other registrants authorized to prescribe, dispense, and administer controlled substances) in their understanding of the federal Controlled Substances Act and its implementing regulations as they pertain to their professions. The manual is accessible on the DEA Web site at www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual090506.pdf. ------------------------------------------------------------------------------- Q: What is my responsibility as a pharmacist in case of drug loss or theft? A: Pursuant to a change in DEA CFR 21-1301.76, (April 1, 2006) – a DEA registrant shall notify the field division office of DEA in writing, of the theft or significant loss of any controlled substances within ONE BUSINESS DAY of discovery of such loss or theft. Registrants are also required to complete a DEA 106 regarding the loss or theft. When determining whether a loss if significant, a registrant should consider the factors listed in 1301.76 (b). A Drug Disaster & Loss Report should also be completed and filed with the NC Board of Pharmacy office within 10 days of the drug loss/theft. To access the report, click here to access the Board's new Gateway. Select the FACILITY MANAGEMENT tab and then select PHARMACY from the pharmacy type drop-down. Log in using your pharmacy permit number, then scroll down to see REPORTS. ------------------------------------------------------------------------------- Q: May a technician, certified technician, or pharmacy student transfer or receive transfers of prescriptions for controlled substances? A: Under federal law, an original prescription for a C-III, C-IV, or C-V substance may be transferred for refill on a one-time basis. If pharmacies electronically share a “real-time, on-line database,” then those sharing pharmacies “may transfer up to the maximum refills permitted by law and the prescriber’s authorization.” 21 C.F.R. § 1306.25(a). Federal law, however, requires that any transfer of a C-III, C-IV, or C-V prescription be “communicated directly between two licensed pharmacists . . . .” 21 C.F.R. § 1306.25(a)(1). Thus, under federal law, neither technicians, nor certified technicians, nor pharmacy students may transfer or receive transfers of prescriptions for controlled substances. -------------------------------------------------------------------------------- Q: Can prescription blanks for controlled substances be pre-printed? A: A North Carolina rule prohibits the preprinting of the name of the controlled substance on prescription blanks. This rule can be found here: NCAC 45.G Drug Commission-Pertinent Rules. A computer-generated controlled substance prescription is not considered “pre-printed” so long as the prescription was generated for an individual patient, and not “mass printed.” Pharmacists should also note that the DEA does not permit the use of electronic or stamped signatures on any controlled substance prescription. -------------------------------------------------------------------------------- Q: What refill authority exists for Physician Assistants, Nurse Practitioners and Clinical Pharmacist Practitioners? -------------------------------------------------------------------------------- Q: Are pharmacists required to "cancel" a prescription for a controlled substance by drawing a line from one corner to the other of the prescription document? A: No, this is not a federal or state requirement.
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