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Pharmacist FAQs

Frequently Asked Questions for Pharmacists on Controlled Substances/Controlled Substance Reporting Act

 

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.

NABP recently collaborated with the Anti-Diversion Industry Working Group (ADIWG) to prepare a video intended to educate pharmacists and increase their awareness of potential red flags when filling controlled substance prescriptions. This video introduces the world of diversion through the eyes of former diverters and abusers who reveal the tricks of their trade. The video illustrates that diverters and abusers can be found in every race, gender, and age group. It’s not always who you think.

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
   As reported in Item 2227 of the October 2011 Newsletter, the North Carolina General Assembly passed, and Governor Perdue signed into law S.L. 2011-349, which requires presentation of a photo identification prior to the dispensing of certain controlled substances.  The statute is an amendment to the North Carolina Controlled Substances Act and codified at N.C.G.S. § 90-106.1 and is effective March 1, 2012.  Board staff has received numerous questions about this statute.  In response, Board staff has developed an FAQ document.

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.

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Q: How do I access the NC Controlled Substances Reporting System?

A: Pharmacists licensed in North Carolina may now apply for access to the NC Controlled Substances Reporting System (CSRS) through the Board of Pharmacy’s website (through the main pharmacist log-in page).  Click here to learn more about the NC CSRS, which is administered by the NC Department of Health and Human Services’ Drug Control Unit.

REGISTER TO ACCESS THE CSRS:
If you are not already registered, CLICK HERE to log in using your license number and PIN (last 4 digits of your Social Security Number), then from the main menu select “CS Reporting.”  Follow the prompts from there to complete and submit the application.

Please note that pharmacists typically do not hold an individual DEA number, so pharmacists are advised to provide the DEA number of the pharmacy where they practice most often.

The completed application will go directly to the NC DHHS Drug Control Unit.  Accordingly, pharmacists with questions should address them to nccontrolsubstance.reporting@dhhs.nc.gov or (919) 733-1765.

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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.

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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.

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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:

§ 1306.12 Refilling prescriptions; issuance of multiple prescriptions.
(a) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited.
(b)(1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met:
(i) Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice;
(ii) The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription;
(iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse;
(iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and
(v) The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law.
(2) Nothing in this paragraph (b) shall be construed as mandating or encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing Schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so.

3. Section 1306.14 is amended by adding a new paragraph (e) to read as follows:

§ 1306.14 Labeling of substances and filling of prescriptions.
(e) Where a prescription that has been prepared in accordance with section 1306.12(b) contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date.


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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 Alex Asbun, Program Manager of the Department of Health and Human Services Drug Control Unit, Alex.Asbun@dhhs.nc.gov.

The act requires dispensers to report:

(1)  The dispenser's DEA number.
(2)  The name of the patient for whom the controlled substance is being dispensed, and the patient's:
            a. Full address, including city, state, and zip code,
            b. Telephone number, and
            c. Date of birth.
(3)  The date the prescription was written.
(4)  The date the prescription was filled.
(5)  The prescription number.
(6)  Whether the prescription is new or a refill.
(7)  Metric quantity of the dispensed drug.
(8)  Estimated days of supply of dispensed drug, if provided to the dispenser.
(9)  National Drug Code of dispensed drug.
(10) Prescriber’s DEA number.

 

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:

a. A licensed hospital or long term care pharmacy that dispenses such substances for the purpose of inpatient administration.
b. A person authorized to administer such a substance pursuant to Chapter 90 of the General Statutes.
c. A wholesale distributor of a Schedule II through V controlled substance.”

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.

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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.

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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.

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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.

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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.

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Q: What refill authority exists for Physician Assistants, Nurse Practitioners and Clinical Pharmacist Practitioners?

A: Summary of Rules on Prescribing by Nurse Practitioners, Physician Assistants and Clinical Pharmacist Practitioners (click to view PDF.)

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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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Q: Where can I find information on the State Controlled Substances Act?

A: Please contact:

Department of Health & Human Services
Controlled Substances Drug Regulatory Branch
3008 Mail Service Center
Raleigh, NC 27699-3008

Phone: (919) 715-2771
Fax: (919) 733-4665

More information here: http://www.ncdhhs.gov/mhddsas/providers/NCcontrolledsubstances/index.htm

 

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