Controlled Substance - Schedule II

Q. What changes can be made on a CII prescription?

A.  From Drug Enforcement and Professional Practices (DEPP) Branch of the OIG, printed in September 2010 Newsletter:

  • After consulting with the prescribing practitioner, a pharmacist may add or modify the following items:

    1. Date of issue – may be added, but not changed

    2. Drug strength

    3. Quantity – may be modified only in conjunction with a change of strength, and the total quantity dispensed must not exceed the total dosage authorized

    4. Quantity check-off box marked

    5. Directions for use

    6. Refill instructions (Schedules III-V)

    7. Practitioner’s name – printed (not a signature)

  • All consultations must be documented. 

  • The following items may be added or modified without consulting the practitioner if the information can be obtained from other reliable sources:

    1. Patient’s address

    2. Dosage form

    3. Practitioner’s address – printed

    4. Practitioner’s telephone number

    5. Practitioner’s DEA number

  • A pharmacist may never change or add the patient’s name, the name of the controlled substance (except generic substitution permitted by state law), or the signature of the practitioner.

Both state and federal law still require professional judgment by the pharmacist on every prescription filled. Caution is advised whenever a change or addition is made to any prescription.


Q. How long is a CII prescription valid?

A. 60 days from the date written  KRS 218A.180


Q. What is the maximum quantity of a CII that may be prescribed for acute pain?

A. KRS 218A: 205, limits the prescribing of a Schedule II controlled substance used to treat acute pain to a 3 day supply. The exceptions are: 

    1. In the professional judgment of the practitioner, more than a 3 day supply is needed.  The need must be documented . For the purposes of pharmacy dispensing, the medical necessity for a Schedule II controlled substance as documented by the practitioner in the patient’s medical record and the prescription for more than a 3 day supply for that controlled substance are presumed to be valid.
    2. Treating chronic pain.
    3. Treating cancer pain.
    4. Treating a patient at end of life or in Hospice.
    5. Part of a narcotic treatment program.
    6. Treatment of pain after major surgery or significant trauma as defined by the licensing Board and the Office of Drug Control Policy.
    7. Dispensed or administered directly to the patient in an inpatient setting.
    8. Scenarios authorized by the licensing board. 
    9. APRNs must still follow prescribing limits set forth in KRS 314.011.

 

Q. What is the maximum quantity of a CII that may be prescribed?

A.   

  1. Other than the 3 day limit for acute pain and the exemptions listed above, MD/DO There is no maximum quantity in state or federal law

  2. Other than the 3 day limit for acute pain and the exemptions listed above, DMD/DDS There is no maximum quantity in state or federal law; however, it should be only of a sufficient amount to treat the patient. KRS 313.035(6)

  3. Other than the 3 day limit for acute pain and the exemptions listed above, DVM There is no maximum quantity in state or federal law. 201 KAR 16:110

  4. Other than the 3 day limit for acute pain and the exemptions listed above, DPM There is no maximum quantity in state or federal law. 201 KAR 25:090

  5. Other than the 3 day limit for acute pain and the exemptions listed above, APRN 3 day supply with exceptions for ADD/ADHD drug if certified in mental health 30 days, KRS 314.011(8) and hydrocodone combination products 30 days. KRS 218A.020(3)

  6. Other than the 3 day limit for acute pain and the exemptions listed above, OD 72 hour supply of hydrocodone combination products, KRS 218A.020(3) but no other CII. KRS 320.240(13)

  7. Other than the 3 day limit for acute pain and the exemptions listed above, PA cannot prescribe any controlled substance in Kentucky


Q. If a physician issues multiple CII prescriptions for a patient, all dated the date issued with instructions to not fill some of the prescriptions until a certain date (a “do not fill until” date), can the pharmacist contact the physician and change the “do not fill until” date?

A. No, when the prescription contains instructions from the physician stating the prescription cannot be filled until a certain date, a pharmacist may not fill the prescription before that date. See “Questions and Answers” on the DEA website (deadiversion.usdoj.gov) under “Issuance of Multiple Prescriptions for Schedule II Controlled Substances.” See also 21 CFR 1306.14(e).


Q. If a patient receives a CII controlled substance prescription and the patient’s insurance will not pay for the full amount, can the pharmacist bill part of the prescription to the insurance and have the patient pay for the remaining amount?

A. This is only allowed if the pharmacy computer system is able to retain the same prescription number.  If the pharmacy computer system assigns a new prescription number to the remaining amount, DEA considers that a refill and it may not be done.  The patient will lose the remaining tablets. 


Q. What are the prescribing limitations for CII stimulants?

A. Physicians may only prescribe CII amphetamine or amphetamine-like substances to treat:

  • Narcolepsy

  • Attention deficit/hyperactivity disorder

  • Resistant depression disorder in conjunction with antidepressants

  • Drug-induced brain dysfunction

  • Investigational use that has been approved by the Kentucky Board of Medical Licensure

  • May not be used to treat obesity

201 KAR 9:016 Section 3