Controlled Substances Questions

Q. Can a controlled substance be e-prescribed in Kentucky?

A. Yes, CII, CIII, CIV and CV prescriptions can be e-prescribed as long as the prescriber software and pharmacy software meet the DEA requirements for electronic prescribing.  KRS 218A.180

Q. How does a pharmacist know if a prescriber’s software meets DEA requirements for e-prescribing?

A. All e-prescriptions must go through the Surescripts exchange.  A controlled substance prescription will not be transmitted if the prescriber software does not meet DEA requirements.  If the prescriber software does meet DEA requirements, there will be a seal stating the prescription is verified.

Q. Can a prescriber use a pre-printed blank for controlled substances?

A. No.  A prescriber can use a computer generated prescription or a stamp.  902 KAR 55:105 Section 3(3)(b)

Q. Can a prescriber use a stamp for controlled substance prescriptions?

A. Yes.  A prescriber can use a stamp for controlled substance prescriptions.  902 KAR 55:105 Section 3(3)(c)

Q. A prescriber’s name is not preprinted on the controlled substance security blank but is handwritten on the blank.  Is this acceptable?

A. Yes, the prescriber’s name, address and telephone number may be preprinted, stamped, typed or manually printed on the prescription.  902 KAR 55:105 Section 3(2)

Q. Can a prescriber use another prescriber’s controlled substance security blank for prescriptions?

A. Yes, as long as the prescriber using the controlled substance security blank stamps, types or manually prints his/her name (and address and telephone number if different) on the prescription blank.  902 KAR 55:105 Section 3(2)

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?

A.   
  1. MD/DO There is no maximum quantity in state or federal law
  2. 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. DVM There is no maximum quantity in state or federal law. 201 KAR 16:110
  4. DPM There is no maximum quantity in state or federal law. 201 KAR 25:090
  5. 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. OD 72 hour supply of hydrocodone combination products, KRS 218A.020(3) but no other CII. KRS 320.240(13)
  7.  PA cannot prescribe any controlled substance in Kentucky

Q. What controlled substances can an APRN prescribe?

A.  CII – 3 day supply, KRS 314.011(8) with exceptions:
ADD/ADHD if certified in mental health 30 days, KRS 314.011(8) and hydrocodone combination products 30 days. KRS 218A.020(3)
     CIII – 30 day supply no refills. KRS 314.011(8)
     CIV – V – 6 month supply, KRS 314.011(8), with exceptions:
          Diazepam (Valium) C IV
          Clonazepam (Klonopin) C IV
          Alprazolam (Xanax) C IV
          Lorazepam (Ativan) C IV
          Carisoprodol (Soma) C IV
All limited to 30 day supply with no refills. 201 KAR 20:059

Q. What controlled substances can an out of state APRN or PA prescribe? 

A.  APRN and PA controlled substance prescribing varies from state to state. Kentucky pharmacists should only dispense a controlled substance prescription for an out of state APRN up to the authority they would have if it were a Kentucky APRN. PA’s in Kentucky do not have controlled substance prescriptive authority, Kentucky pharmacists should not accept or dispense controlled substance prescriptions written by an out of state PA. 

Q. Can a pharmacist refuse to dispense a controlled substance prescription?

A. Yes, a pharmacist has a corresponding responsibility along with the prescriber to make sure controlled substance prescriptions are written for a legitimate patient, for a legitimate medical need in the usual course of practice of the prescriber. Title 21 CFR 1306.04 KRS 218A.180(3)

Q. What can a pharmacist do to determine the validity of a controlled substance prescription, thus demonstrating corresponding responsibility?

A. There are red flags a pharmacist can look for when trying to determine the validity of a prescription.  This list is not inclusive and does not take the place of a pharmacist’s professional judgment. 
  • Does the pharmacist have a relationship with the prescriber?
  • Does the pharmacist have a relationship with the patient?
  • What is the distance a patient is driving to see the prescriber?
  • What is the home address of the patient?
  • In what community is the prescriber practicing?
  • Have people unknown to the pharmacist called asking if a specific medication or a specific manufacturer of a medication is stocked by the pharmacy?
  • When prescriptions are filled for one patient, do many, many more start coming to the pharmacy?
  •  Is every patient receiving the exact same prescriptions?
  • Does the prescriber take cash only? 

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.”

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. Can a pharmacist dispense a partial amount of a CIII-V prescription resulting in a greater number of dispensing than the number of refills prescribed?

A. Yes.  A refill is for the full amount prescribed.  If a partial refill is dispensed, the pharmacist must record the date, quantity dispensed, responsible pharmacist and quantity remaining.  See Questions and Answers on the DEA website (deadiversion.usdoj.gov) under “Prescriptions”

Q. Under what circumstances can a pharmacist dispense a partial amount of a CII prescription and the patient does not lose the amount remaining?

  1. When the pharmacy is unable to supply, meaning the pharmacy is out of the medication.  The pharmacist has 72 hours to dispense the remaining amount.
  2. When the patient is terminally ill (for example in Hospice) and it is documented on the face of the prescription, the pharmacist has 60 days to dispense the full quantity of the prescription.
  3. When the patient is in a long term care facility, the pharmacist has 60 days to dispense the full quantity of the prescription. 

Q. How many times can a controlled substance be transferred?

A.  One time only, unless pharmacies electronically share a real-time, online database, then may transfer as many times as there are refills. Title 21 CFR 1306.25

Q. Can an intern transfer a controlled substance prescription?

A. No, a controlled substance prescription must be transferred between two pharmacists or via a real-time, online database. Title 21 CFR 1306.25

Q. Can a technician transfer a controlled substance prescription?

A. No, a controlled substance prescription must be transferred between two pharmacists or via a real-time, online database. Title 21 CFR 1306.25

Q. Can a physician write a controlled substance prescription for himself?

A. No.  201 KAR 9:260

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

Q. What are the prescribing limitations for physicians for CIII anorectics?

Q. Does the patient’s bmi have to be recorded on a phentermine prescription?

A. No.

Q. What are the prescribing limitations for physicians for buprenorphine?

A. When finalized 201 KAR 9:270

Q. Can an APRN prescribe buprenorphine?

A. Not for office based addiction treatment, but an APRN may prescribe Butrans or buprenorphine in the form of Suboxone, Subutex, or the generics for an off label use (pain). 

Q. Is an ID required to pick up a controlled substance prescription?

A. No, but the pharmacy can choose to require it.

Q. Is there an age requirement to pick up a controlled substance prescription?

A. No.