Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This rule implements the provisions of section
338.400,
RSMo, and establishes pharmacy standards for dispensing blood-clotting
products.
(1) Definitions. The
following definitions are hereby adopted and applicable to this rule:
(A) "Bleeding disorder," a medical condition
characterized by a deficiency or absence of one (1) or more essential
blood-clotting components in the human blood, including all forms of
hemophilia, acquired hemophilia, von Willebrand's disease, and other bleeding
disorders that result in uncontrollable bleeding or abnormal blood-clotting. As
defined by section
338.400,
RSMo, "bleeding disorder" does not include a bleeding condition secondary to
another medical condition or diagnosis, except for acquired
hemophilia;
(B) "Blood-clotting
product," a medicine approved for distribution by the federal Food and Drug
Administration (FDA) that is used for the treatment and prevention of symptoms
associated with bleeding disorders, including, but not limited to, recombinant
and plasma derived factor products, von Willebrand factor products,
antifibrinolytics, bypass products for patients with inhibitors, prothrombin
complex concentrates, and activated pro-thrombin complex concentrates. Except
as otherwise provided by section
338.400,
RSMo, a "blood-clotting product" does not include medical products approved
solely for the treatment or prevention of side effects of a blood-clotting drug
or medication;
(C) "Established
patient," For purposes of section
338.400,
RSMo, and this rule, an "established patient" shall be defined as a bleeding
disorder patient that has been dispensed a legend blood-clotting product by the
pharmacy on more than three (3) occassions in a single calendar year;
and
(D) "Pharmacy," an entity
engaged in the practice of pharmacy as defined in section
338.100,
RSMo, that provides blood-clotting products and ancillary infusion equipment or
supplies to patients with bleeding disorders.
(2) General Requirements. All Missouri
licensed pharmacists and pharmacy permit holders shall comply with the
following requirements when dispensing blood-clotting factor concentrates:
(A) Prescriptions for blood-clotting factor
concentrates shall be dispensed as written or authorized by the prescribing
physician, in accordance with state and federal law. No changes or
substitutions shall be made unless approved by the prescriber. If the pharmacy
has received prescriber authorization to change or substitute the
blood-clotting factor concentrate originally prescribed, the patient or the
patient's designee shall be notified and counseled regarding the change or
substitution prior to dispensing via the preferred contact method identified by
the patient or designee pursuant to subsection (2)(E);
(B) If requested by the patient or the
patient's designee, the pharmacy shall ship and deliver blood-clotting factor
concentrates to the patient or the patient's designee as prescribed within two
(2) business days of receiving a prescription or refill request for established
patients and three (3) business days for new patients in nonemergency
situations. Nonemergency situations shall include, but may not be limited to,
routine prophylaxis requests. Appropriate cold chain management and packaging
practices must be used to ensure proper drug temperature, stability, integrity,
and efficacy are maintained during shipment in accordance with manufacturer
requirements;
(C) Patients must be
provided with a designated pharmacy contact telephone number for reporting
problems with a delivery or product on each dispensing at no cost to the
patient;
(D) Unless otherwise
authorized by the patient or the patient's designee, the pharmacy shall contact
the patient for authorization to dispense prior to shipping a refill of any
blood-clotting product to the patient. The date of patient authorization shall
be documented in the pharmacy's prescription records;
(E) Barring extenuating circumstances,
prescriptions for blood clotting factor concentrates shall be dispensed within
plus or minus ten percent (10%) of prescribed assays, or as otherwise
authorized or directed by the prescriber; and
(F) Recalls or Withdrawals. Prior to
dispensing any blood clotting factor concentrate, the pharmacy shall ask the
patient or the patient's designee to designate a preferred contact method for
receiving notifications in the event of a recall or withdrawal of the
concentrate dispensed or any related ancillary infusion equipment and supplies
dispensed by the pharmacy. The preferred contact method shall be documented
with the patient information required by
20 CSR
2220-2.190(2).
1. Notice of concentrate or ancillary
infusion equipment and supplies recalls and withdrawals shall be provided to
the patient via the patient's preferred contact method within twenty-four (24)
hours of receipt of a recall or withdrawal notification from the manufacturer
or any state or federal entity that requires or recommends patient
notification. The pharmacy shall also notify the prescribing physician within
twenty-four (24) hours of such recall or withdrawal and shall obtain a
prescription for an alternative product if a new or amended prescription is
required to dispense or deemed necessary and appropriate by the
prescriber.
2. If attempts to
contact the patient via the preferred contact method are unsuccessful, the
pharmacy shall mail notification to the patient or the patient's authorized
designee within the required twenty-four (24) hours or the next business
day.
3. The time, date, and method
of notification to the patient and prescriber shall be documented in the
pharmacy's records and maintained for two (2) years from the date of recall or
withdrawal.
(3) In addition to the provisions of section
(2), pharmacies that dispense blood-clotting products to established patients,
or that offer or advertise to provide blood-clotting products specifically for
bleeding disorder patients, shall comply with the following standards of care:
(A) The pharmacy shall annually notify the
board in writing of the pharmacy's intent to provide legend blood-clotting
products for bleeding disorder patients. Notification shall be made on or
before January 31 of each calendar year in a manner and form approved by the
board;
(B) The pharmacy shall
identify in advance, or make arrangements with, a supplier or suppliers capable
of providing all brands, assays, and vial sizes of blood-clotting products
approved by the federal FDA, including products manufactured from human plasma
and those manufactured from recombinant technology techniques. A list of all
designated or identified suppliers shall be maintained at the pharmacy and made
available during inspection. This requirement shall not be construed to require
a pharmacy to purchase products prior to receiving a valid prescription
order;
(C) A pharmacist shall be
available twenty-four (24) hours a day, seven (7) days a week, every day of the
year, either on-site or on call, to fill prescriptions for blood-clotting
products, within the time frames designated by section
338.400,
RSMo, and the provisions of this rule;
(D) Pharmacists engaged in dispensing or
filling blood-clotting factor concentrates or who provide patient counseling
regarding blood-clotting factor concentrates to bleeding disorder patients
shall have sufficient knowledge, experience, and training to perform the duties
assigned. To ensure continued competency, pharmacists engaged in counseling
bleeding disorder patients shall complete four (4) continuing education hours
(0.40 CEU) related to blood-clotting factor concentrates, infusion treatment or
therapy, or blood-clotting disorders or diseases each biennial renewal period.
The continuing education required by this rule may be used to satisfy the
pharmacist's continuing education requirements. Proof of compliance with this
section shall be maintained at the pharmacy for a minimum of four (4) calendar
years and shall be made available during inspection or at the request of the
board;
(E) If requested by the
patient or the patient's designee, the pharmacy shall provide for the shipment
and delivery of blood-clotting products to the patient or the patient's
designee as prescribed within two (2) business days of receiving a prescription
or refill request for established patients and three (3) business days for new
patients in nonemergency situations;
(F) Established patients shall be provided
access to blood-clotting products within twelve (12) hours of notification from
a physician of the patient's emergent need for a blood-clotting product. For
purposes of this section, determination of an emergent need shall be within the
professional medical judgment of the physician. Emergent need requests shall be
documented in the pharmacy's prescription records;
(G) The pharmacy shall provide or have
available for purchase containers for the disposal of hazardous waste,
including, but not limited to, sharp or equivalent biohazard waste
containers;
(H) At a minimum, the
pharmacy shall provide or have available for purchase ancillary equipment and
supplies required to infuse a blood-clotting therapy product into a human vein,
including, syringes, needles, sterile gauze, field pads, gloves, alcohol swabs,
numbing creams, tourniquets, medical tape, and cold compression packs. If
supplies are depleted, the pharmacy shall restock the required ancillary
equipment and supplies in a reasonable amount of time which shall not exceed
seven (7) calendar days;
(I) The
pharmacy shall have contact information available for a nurse or nursing
service or agency with experience in providing infusion related nursing
services or nursing services for bleeding disorder patients if such services
are not provided by the pharmacy;
(J) If requested by the patient or the
patient's authorized designee, the pharmacist shall explain any known insurance
copayments, deductibles, coinsurance payments, or lifetime maximum insurance
payment limits. For purposes of complying with this section, the pharmacy may
rely on information supplied by the patient's insurer; and
(K) The pharmacy shall register with the
National Patient Notification System, or its successor, to receive recall
notification for all products included in the National Patient Notification
System. The pharmacy shall maintain current and accurate contact information
with the National Patient Notification System.
(4) Pharmacies that provide legend
blood-clotting products to treat or prevent symptoms of established bleeding
disorder patients, or that offer or advertise to provide blood-clotting
products specifically for bleeding disorder patients, shall develop and follow
written policies and procedures to ensure compliance with section
338.400,
RSMo, and the provisions of this rule. The pharmacy shall review the policies
and procedures on an annual basis and document such review. At a minimum, the
pharmacy's written policies and procedures must include procedures for:
(A) Processing prescriptions for
blood-clotting products by pharmacy staff to ensure the timely handling and
dispensing of blood-clotting products;
(B) Processing partial fill requests by
patients to reduce or eliminate excessive dispensing;
(C) Providing and documenting recall
notifications in accordance with this rule;
(D) Transferring, dispensing, refilling, or
delivering blood-clotting factor concentrates to established patients in the
event of an emergency or disaster;
(E) Notifying patients prior to terminating
business or terminating the dispensing of any blood-clotting factor concentrate
or prior to a known or an anticipated termination of pharmacy services for a
bleeding disorder patient. Notification shall be provided in writing and, when
reasonably possible, shall be provided a minimum of seven (7) days prior to any
such termination;
(F) Shipping or
providing blood-clotting products to the patient within the time frames
required herein;
(G) Receiving,
processing, and dispensing prescription or dispensing requests for a
blood-clotting product to bleeding disorder patients, including procedures for
handling and processing physician request indicating a patient's emergent need
for a blood-clotting product;
(H)
Ensuring appropriate cold chain management and packaging practices are used to
ensure proper drug temperature, stability, integrity, and efficacy are
maintained during shipment in accordance with manufacturer requirements;
and
(I) Handling and processing
preauthorization notifications and requests and communicating preauthorization
requirements to the patient and applicable prescriber.
(5) This rule shall not be construed to
require dispensing without appropriate payment or payment arrangements. If the
pharmacy is waiting for authorization, certification, or other action from a
third-party payer prior to dispensing, the pharmacy shall notify the patient
that the prescription is available for dispensing and explain any alternative
payment options. Notification shall be provided as soon as reasonably
practicable. At a minimum, however, notification shall be provided to the
patient prior to the expiration of the shipping and delivery time frames
required by subsection (2)(E), (3)(B), or (3)(F) of this rule.
*Original authority: 338.140, RSMo 1939, amended 1981,
1989, 1997, 2011 ; 338.280, RSMo 1951, amended 1971, 1981; and 338.400, RSMo
2011.