Pharmacist FAQsFrequently Asked Questions for Pharmacists on Controlled Substances/Controlled Substance Reporting Act
THURSDAY, JANUARY 5, 2012 - PHOTO ID FAQ UPDATE Questions Regarding S.L. 2011-349, Photo Identification Prior to Dispensing Certain Controlled Substances
MONDAY, AUGUST 30, 2010 CONTINUING UPDATE ON ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCES. Board staff continues to receive many inquiries concerning electronic prescriptions for controlled substances (CSERx). By way of recap: The DEA issued a CSERx rule that was “effective” earlier this year. As noted in prior updates, however, the rule is “effective” only in the academic sense. That rule requires any system that either transmits or receives CSERx to be “certified” as meeting DEA’s security and control standards in the CSERx rule. As of today DEA has not certified any transmitting or receiving system as meeting these security standards. Accordingly, CSERx’s still do not meet federal law requirements. Much more information about the rule and its operation may be found here: http://www.ncbop.org/faqs/Pharmacist/ControlledSubstanceE-RXFAQsApr2010.pdf. The DEA has published FAQ guidance on CSERx, which is found here: http://www.deadiversion.usdoj.gov/ecomm/e_rx/index.html#faq. So where does that leave everyone? Basically, at the same place we’ve been all along. Any electronically signed prescription for a controlled substance does not satisfy federal law at this time. DEA has also stated clearly (see the DEA FAQ link above) that prescribers may not print out or print out and fax a prescription for a controlled substance that is electronically signed. Rather, the practitioner may print or print/fax a controlled substance prescription that they have actually signed (with the exception of C-II prescriptions, which may be faxed only for residents of long-term care facilities or for terminally ill patients). A pharmacist who receives an electronic prescription for a Schedule III, IV, or V medication may call the prescriber, confirm the prescription, and treat it as a verbal order. Board staff is aware that a number of physicians and physician office managers have insisted – often vehemently – that electronic prescriptions for controlled substances are allowable. This insistence, however well intentioned, is simply not correct. Board staff has asked that the North Carolina Medical Board communicate this information to their licensees to clear up confusion. Unquestionably, the state of being for CSERx is one that is frustrating and confusing. Let’s all hope that the DEA will – and will quickly – certify some CSERx prescribing systems. In the meantime, Board staff encourages pharmacists and prescribers to communicate with their electronic prescribing system vendors about those vendors’ efforts to become certified. Those wishing to register complaints about the implementation – or lack thereof – of the CSERx rule should contact the DEA. Board staff will continue to provide updates on this issue. FRIDAY, APRIL 16, 2010 DEA ISSUES “INTERIM FINAL RULE” ON ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCES. On Wednesday, March 24, 2010, the DEA issued an “interim final rule” concerning electronic prescriptions for controlled substances. This rule, which will not go into effect until May 24, 2010 at the earliest, is lengthy. Pharmacists should begin reviewing the rule and, particularly, contacting your software and hardware vendors to discuss the security and other requirements that DEA specifies for receipt of electronic controlled substance prescriptions. The text of the interim final rule may be found here. Note that the document is long (334 pages). Most of the document is devoted to responding to comments DEA received on its proposed rule in 2008. CLICK HERE TO READ FAQs ON ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCES. ------------------------------------------------------------------------------------------ Click here to view/download our Controlled Substances reference pocket-card. ------------------------------------------------------------------------------------------ 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 Substance Reporting System? A: Pharmacists in North Carolina may apply for access to the NC CSRS. The Department of Health and Human Services’ Drug Control Unit, which administers the CSRS, has information and instructions here: http://www.ncdhhs.gov/mhddsas/controlledsubstance/. The application for access to the CSRS (located here: http://www.ncdhhs.gov/mhddsas/controlledsubstance/csrs-applicationform6-10.pdf) asks for a DEA number, and accompanying instructions (located here: http://www.ncdhhs.gov/mhddsas/controlledsubstance/csrs-profaccess6-10-instruct.pdf state that “your DEA # will be your user name.” Pharmacists typically do not hold an individual DEA number. Bill Bronson, Director of the Drug Control Unit, instructs that a pharmacist’s license number is used for access to the CSRS. When completing the access form, a pharmacist should provide the DEA number of the pharmacy where he/she practices most often. Most importantly, however, the pharmacist must provide his/her pharmacist license number when completing the form. Pharmacists with questions should address them to Mr. Bronson (william.bronson@dhhs.nc.gov; (919) 733-1765). ------------------------------------------------------------------------------------------ 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 (http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-22558.pdf), 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:
APhA's statement to the DEA on the proposed regulation can be accessed here. -------------------------------------------------------------------------------- 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 Johnny Womble of the Department of Health and Human Services, johnny.womble@ncmail.net. 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. ------------------------------------------------------------------------------- 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 preprinted? A: A North Carolina rule prohibits the preprinting of the name of the controlled substance on prescription blanks. This rule can be found at NCAC45.G Drug Commission-Pertinent Rules on the Board’s Website under Drug Law. -------------------------------------------------------------------------------- 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. -------------------------------------------------------------------------------- Q: Where can I find information on the State Controlled Substances Act? A: Please contact: Department of Health & Human Services Phone: (919) 715-2771 More information here: http://www.ncdhhs.gov/mhddsas/providers/NCcontrolledsubstances/index.htm
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