Ohio State Regulatory Update April 2019
Senate Bill 1446: Immediate Release Opioids
SB 1446 applies only to immediate release opioids prescribed for acute pain and includes tramadol and codeine products. Buprenorphine is not included in this law. Diagnosis for "acute vs chronic" pain is not required on the prescription; however, insurance policies or company policies may require it. Pharmacists may ask the patient, check the prescription monitoring program, check the patient profile, or contact the prescriber to verify if the prescription is for "acute vs chronic" pain. Pharmacists are not required to verify acute pain diagnosis and will need to utilize their professional judgment.
The initial prescription for an acute pain event can be issued for a seven-day supply to be determined by the prescriber.
If a second prescription is needed, then the prescriber, after consultation with the patient, can issue another prescription for a seven-day supply.
If a third prescription is needed, there must be a written agreement, pain management agreement, or pain management contract in place between the prescriber and the patient. Pharmacists are not required to make sure this contract is in place. However, this information may be requested during the counseling and verification process.
If the patient is on chronic pain medication and has an acute event, then the pharmacist will carefully evaluate the impact of adding an immediate release opioid to the patient's therapy.
475:30-1-4. Manner of issuance of prescriptions
A practitioner must state on a written prescription for any controlled dangerous substance the name, address and DEA registration number of the practitioner; the date of delivery of the prescription; the name, dosage and strength per dosage unit of the controlled dangerous substance;
the name and address of the patient, or if it is a veterinary prescription, the species of the animal and the name and address of the owner;
the directions for use and any cautionary statements required; and
if allowable, the number of times to be refilled.
The face of a prescription must not be materially altered; if an error is made in filling out the prescription, a new prescription must be written by the prescribing practitioner. A pharmacist may add to the prescription the patient's address or age, the prescribing practitioner's federal DEA number, or the generic drug name if used.
After confirming with the prescribing practitioner, the pharmacist may add information indicating the strength, whether tablet or capsule form, and whether it is compounded if such additions would not materially alter the prescription.
If omitted, the directions (Sig) or the quantity, may be added by the pharmacist after confirming with the prescribing practitioner.
Documentation of contacting the prescribing practitioner will be noted on the back of the prescription regarding the items above.
A written prescription for a controlled dangerous substance in Schedule II becomes invalid thirty (30) days after the date of issuance, with day one (1) of the thirty (30) day period being the first day after the date of issuance.
After issuing an initial prescription pursuant to Section 2-309I of Title 63, an individual practitioner may issue one (1) subsequent prescription for an immediate-release opioid drug in Schedule II in a quantity not to exceed seven (7) days if the subsequent prescription is due to a major surgical procedure and/or "confined to home" status as; the practitioner provides the subsequent prescription on the same day as the initial prescription; the practitioner provides written instruction on the subsequent prescription indicating the earliest date on which the prescription may be filled (i.e. "do not fill until" date); and the subsequent prescription is dispensed no more than five (5) days after the "do not fill until" date indicated on the prescription.
Each scheduled drug shall be written on a single prescription form, and no other prescriptions (controlled or non-controlled) shall be written on the same prescription form.
19.03 Out-of-State Mid-Level Practitioners
Pharmacies can now fill non-controlled dangerous substance (CDS) prescriptions from out-of-state optometrists, physician assistants, and advanced practice registered nurses. For pharmacies to fill CDS prescriptions from out-of-state optometrists, the optometrist needs to be licensed in Oklahoma. For pharmacies to fill CDS prescriptions from out-of-state physician assistants and advanced practice registered nurses, they need to be licensed in Oklahoma and supervised by an Oklahoma licensed physician.
This law became effective on November 1, 2018
.What does this mean for pharmacists practicing in the state of Oklahoma?
- Pharmacists must be aware of all requirements around the prescribing and dispensing of controlled substance/opioid medications and ensure that all staff are also trained in these requirements. Proper documentation of all changes and additions allowed by regulation must follow the above guidance. While pharmacists are not required by law to regulate prescriber requirements, strong professional judgement is required to ensure patient safety in all circumstances.
- Pharmacists must also be aware of the regulations for out of state prescribers. Proper validation of out of state prescriber registration is required for proper and legal dispensing of mediations. Ensure that all staff are properly trained to avoid potential delays in patient therapy.
Oklahoma State Regulatory Summary- November 2018
SB 1446: Regulation of opioid drugs; providing limitations on quantities of certain prescriptions.
475:30-1-4. Manner of issuance of prescriptions
- A written prescription for a controlled dangerous substance in Schedule II becomes invalid thirty (30) days after the date of issuance, with day one (1) of the thirty (30) day period being the first day after the date of issuance.
- After issuing an initial prescription pursuant to Section 2-309I of Title 63, an individual practitioner may issue one (1) subsequent prescription for an immediate-release opioid drug in Schedule II in a quantity not to exceed seven (7) days if:
- The subsequent prescription is due to a major surgical procedure and/or "confined to home" status as defined in 42 U.S.C. 1395n(a);
- The practitioner provides the subsequent prescription on the same day as the initial prescription;
- The practitioner provides written instruction on the subsequent prescription indicating the earliest date on which the prescription may be filled (i.e. "do not fill until" date); and,
- The subsequent prescription is dispensed no more than five (5) days after the "do not fill until" date indicated on the prescription.
What do these new regulations mean for pharmacists practicing within the state of Oklahoma?
Pharmacists must be informed of these new dispensing requirements on schedule II-controlled substances containing opioids. They must also ensure that all staff are aware, to maintain compliance with the law and also provide education to their patients.
Oklahoma State Regulatory Summary- 2017
The below laws, summarized below, were enacted by the Oklahoma legislature during the 2017 session. All were effective September 11, 2017.
Chapter 1:Administrative Operations
Changes related to hearings made to current regulation.
Chapter 15:Pharmacies
- Amended responsibilities to include pharmacist in charge duties, automated dispensing systems, and identification badge requirements for staff.
- Hospital pharmacy duties amended to include remote order processing rules, emergency dispensing, and pre-packing of medication.
- Non-sterile compounding rules amended to include guidance for bulk compounding and OTC products; compounding for physicians' offices has been revoked.
- Amendments made to provide additional guidance provided around supportive personnel duties.
- New and updated guidance provided for nuclear pharmacy.
- Establishes guidance regarding personnel criteria at outsourcing facilities
Chapter 25:Rules Affecting Various Registrants
- Defines an incorrect medication fill as a violation of registrant conduct.
What do these new regulations mean for pharmacists practicing within the state of Oklahoma?
- Pharmacists must have a good understanding of how these new rules and amendments affect their area of practice, if applicable.
- Special attention must be made to support staff limitations of duties and review current policies and standard operating procedures to ensure that they align with the most current rules.
For full regulatory language, refer to the Oklahoma Board of Pharmacy.
