Missouri State Regulatory Update April 2019
The Board recently revised 20 CSR 2220-6.050 (Immunization by Protocol) to streamline Missouri's immunization requirements:
- Mileage Limits Protocol physician - No mileage restrictions.
- Minimum Patient Age- The minimum age authorized by law which is currently seven (7) years old or the age recommended by the Centers for Disease Control and Prevention, whichever is higher (unless otherwise restricted by protocol).
- Authorized Immunization Locations -Only nonpharmacy sites must be listed in the protocol.
- Notifications of Intent Annual renewal required Must be renewed every two (2) years with your Missouri pharmacist license.
- Vaccine Notifications- Protocol physician must be notified as designated in the governing protocol; No minimum time limit set by rule. *Notification of adverse events still required within 24 hours.
- Continuing Education- Two (2) hours of CE required each biennial renewal period (11/1 of even numbered years to 10/31 of even numbered years).
- Licensees should review 20 CSR 2220-6.050 for a complete listing of the updated requirements.
- The Pharmacist Administration/ Immunization Checklist brochure has also been updated and is available on the Board's website.
What does this mean to pharmacists practicing in the state of Missouri?
- Immunizing pharmacies will have more options in obtaining physicians for their immunization protocols, reporting vaccine administration to the protocol physician, and lowered the minimum age for vaccine administration per a protocol. Pharmacists should check and update their protocols to make sure the protocol includes/allows the rule changes such as the lower immunization age. Compliance with your protocol is mandatory even though the rule has changed.
- All pharmacies must also ensure that the most current Immunization Checklist brochure is being used.
Missouri Regulatory Update November 2018
20 CSR 2220-2.200 Sterile Compounding.
Clarifies the requirements for in-use times/beyond-use dating and remedial investigations as the result of environmental monitoring.
- Aseptic Technique and Preparation.
Single-dose vials/containers and pharmacy bulk vial/containers exposed to ISO Class 5 or cleaner air may be used in compounding until the assigned in-use time which shall not exceed six hours after initial needle puncture, unless otherwise specified by the manufacturer. Opened single-dose ampules shall not be stored for any time period. The in-use time must be placed on the vial/container. For multiple-dose vials/containers with no antimicrobial preservative used in the preparation of radiopharmaceuticals whose beyond-use dates are twenty-four hours or less, the in-use time shall not exceed twenty-four hours.
Remedial Investigations.
A remedial investigation shall be required if any environmental monitoring sample demonstrates a colony forming unit (CFU) count that exceeds USP Chapter 797 recommended action levels for the type of sampling. The amendment also provides guidance on when a pharmacy must cease compounding until the investigation is complete and board notification requirements.
Sterile Compounding
SB826 Practice of Pharmacy
Section 195.080: Opioid Prescribing and Dispensing Restrictions
- A practitioner, other than a veterinarian, shall not issue an initial prescription for more than a seven-day supply of any opioid controlled substance upon the initial consultation and treatment of a patient for acute pain.
- If, in the professional medical judgment of the practitioner, more than a seven-day supply is required to treat the patient's acute pain, the practitioner may issue a prescription for the quantity needed to treat the patient; provided, that the practitioner shall document in the patient's medical record the condition triggering the necessity for more than a seven-day supply and that a nonopioid alternative was not appropriate to address the patient's condition.
- The provisions of this subsection shall not apply to prescriptions for opioid controlled substances for a patient who is currently undergoing treatment for cancer, is receiving hospice care from a hospice certified in palliative care, is a resident of a long-term care facility, or is receiving treatment for substance abuse or opioid dependence. A pharmacist or pharmacy shall not be subject to disciplinary action or other civil or criminal liability for dispensing or refusing to dispense medication in good faith pursuant to an otherwise valid prescription that exceeds the prescribing limits established. The quantity of Schedule II controlled substances prescribed or dispensed at any one time shall be limited to a thirty-day supply.
- The supply limitations provided in this subsection may be increased up to three months if the physician describes on the prescription form or indicates via telephone, fax, or electronic communication to the pharmacy to be entered on or attached to the prescription form the medical reason for requiring the larger supply.
Section195.265: Controlled Substance Disposal
- Unused controlled substances may be accepted from ultimate users, from hospice or home health care providers on behalf of ultimate users to the extent federal law allows, or from any person lawfully entitled to dispose of a decedent's property if the decedent was an ultimate user who died while in lawful possession of a controlled substance, even if the authorized collector did not originally dispense the drug.
Section 338.010: Administration of Immunizations
- The administration of viral influenza, pneumonia, shingles, hepatitis A, hepatitis B, diphtheria, tetanus, pertussis, and meningitis vaccines by written protocol authorized by a physician for persons at least seven years of age or the age recommended by the Centers for Disease Control and Prevention, whichever is higher, or the administration of pneumonia, shingles, hepatitis A, hepatitis B, diphtheria, tetanus, pertussis, meningitis, and viral influenza vaccines authorized by a physician for a specific patient as authorized.
- A pharmacist shall inform the patient that the administration of the vaccine will be entered into the ShowMeVax system. The patient shall attest to the inclusion of such information in the system by signing a form provided by the pharmacist. If the patient indicates that he or she does not want such information entered, the pharmacist shall provide a written report within fourteen days of administration of a vaccine to the patient's primary health care provider, if provided by the patient.
Section 338.056: Substitutable and interchangeable products
- A pharmacist filling prescription orders for drug products prescribed by trade or brand name may select another drug product with the same active chemical ingredients of the same strength, quantity and dosage form, and of the same generic drug or interchangeable biological product type, as determined by the United States Adopted Names and accepted by the Federal Food and Drug Administration. The pharmacist shall assume the same responsibility for that selection. The pharmacist shall not select a drug or interchangeable biological product pursuant to this section unless the product selected costs the patient less than the prescribed product. The pharmacist shall note the instructions on the file copy of the prescription.
- A pharmacist may, unless the prescriber has specified on the prescription that dispensing a prescription for a maintenance medication in an initial amount followed by periodic refills is medically necessary, a pharmacist may exercise his or her professional judgment to dispense varying quantities of maintenance medication per fill, up to the total number of dosage units as authorized by the prescriber on the original prescription, including any refills, but shall be limited to no more than a ninety-day supply of the medication, and the maintenance medication shall have been previously prescribed to the patient for at least a three-month period.
Section 376.387: Cost saving discussions on medications
- No pharmacy benefits manager shall include a provision in a contract entered into or modified on or after August 28, 2018, with a pharmacy or pharmacist that requires a covered person to make a payment for a prescription drug at the point of sale in an amount that exceeds the lesser of the copayment amount as required under the health benefit plan or the amount an individual would pay for a prescription if that individual paid with cash.
- A pharmacy or pharmacist shall have the right to provide to a covered person information regarding the amount of the covered person's cost share for a prescription drug, the covered person's cost of an alternative drug, and the covered person's cost of the drug without adjudicating the claim through the pharmacy benefits manager.
- Neither a pharmacy nor a pharmacist shall be proscribed by a pharmacy benefits manager from discussing any such information or from selling a more affordable alternative to the covered person.
- No pharmacy benefits manager shall, directly or indirectly, charge or hold a pharmacist or pharmacy responsible for any fee amount related to a claim that is not known at the time of the claim's adjudication, unless the amount is a result of improperly paid claims or charges for administering a health benefit plan.
For more information, refer to SB826 Complete Ruling
HB 1719
Section 337.718: New CE requirement for pharmacists for licensure
Any licensee that provides health services must complete 2 hours of suicide assessment, referral, treatment, and management training.
Section 338.315: Purchase of legend drugs by a pharmacy
Except as otherwise provided by the board by rule, it shall be unlawful for any pharmacist, pharmacy owner or person employed by a pharmacy to knowingly purchase or receive any legend drugs under 21 U.S.C. Section 353 from other than a licensed or registered drug distributor, drug outsourcer, third-party logistics provider, or licensed pharmacy.
Pharmacies shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of legend drugs. Such records shall be maintained for two years and be readily available upon request by the board or its representatives.
For full regulation details, refer to HB1719.
What does this mean for pharmacists practicing within the state of Missouri?
- Any pharmacist that performs aseptic compounding must ensure that their standard operation and quality procedures incorporate direction for beyond-use dating and investigations.
- Pharmacists must understand the new requirements for controlled substance and opioid prescribing and dispensing; be prepared to discuss these new requirements with patients receiving prescriptions for pain control.
- The state regulation now allows for immunizations to be administered via a protocol or patient specific prescription, by a certified pharmacist, to patients 7 or older. Ensure that current protocols are updated to reflect this new age limit, and that all staff are aware and duly trained.
- Pharmacists can now provide information concerning prescribed medications, including cost saving alternative substitutions and cost options, without penalty from pharmacy benefit managers. This can allow pharmacists to play a larger part in promoting medication adherence and reducing interruption of therapy due to cost concerns by the patient.
- Pharmacists must complete two hours of suicide assessment and management training prior to license renewal. Ensure that your CE profile reflects this new requirement.
Missouri State Regulatory Summary- 2018
No new pharmacy legislation was passed during the 2018 General Assembly Sessions
*Full legislature documents can be found at the Missouri legislative site at Missouri Legislature.
What do these new regulations mean for pharmacists practicing within the state of Missouri?
For full regulatory language, refer to the Missouri Board of Pharmacy.
