ADD/ADHD C-II Medication Policy & Procedure

ADD/ADHD C-II Medication Policy & Procedure

1.     A practitioner can write for a 90-day supply at one time (with some limitations - see attached document).

2.     No refills on C-II medications are permitted under Federal law (21 C.F.R. § 1306.12)

A prescriber may issue separate, “do not fill until [date]” prescriptions for Schedule II controlled substances, up to a 90-day total supply (over three 30-day prescriptions).

  1. A practitioner does NOT need to evaluate a patient on a regular basis before writing prescriptions. However, usually the patient should be seen a minimum of once a year by the prescriber to demonstrate existence of an ongoing patient-provider relationship.

4.   A patient does NOT need to pick up the prescription for a C-II medication in person.  Prescriptions may be mailed to the patient or to the patient's pharmacy.

5.  It should be required that the person picking up a filled C-II medication have a valid, unexpired photo identification that must be one of the following: drivers license

 

Federal law overview  [21 C.F.R. § 1306.11(a)]

  • In December 2008, DEA finalized a rule that allows a prescriber to issue separate, “do not fill until [date]” prescriptions for Schedule II controlled substances, up to a 90-day total supply. 
  • No refills on C-II medications permitted under federal law (21 C.F.R. § 1306.12)
  • Can write prescriptions for up to a 90-day supply (over several 30-day prescriptions)
    • Prescriptions must:
      • Be numbered in sequential order
      • Have the current date (i.e. date written) on all 3 prescriptions
      • Contain a “do not fill until [date]” on the prescription for the future prescriptions
      • Can include different instructions, if necessary
  • Prescriptions must contain:
    • Name and address of the patient
    • Drug name, strength, and dosage form of the medication
    • Quantity to be dispensed
    • Name, address, and DEA registration number of the prescriber
    • Prescriber must sign the prescription on date of issuance

(1)                From 21 C.F.R. § 1306.12:  “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

(iv)              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.

 

 

Sources:

Drug Enforcement Administration.  Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act.  Revised 2010. [cited 2012 May 5]; Available from: http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf