Pharmacy Standards for Dispensing Blood-Clotting Products

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 prothrombin 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 onsite 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 AND INSURANCE (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. AUTHORITY: section 338.280, RSMo 2000, and sections 338.140 and 338.400, RSMo Supp. 2012.* Original rule filed Nov. 13, 2012, effective May 30, 2013. *Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011; 338.280, RSMo 1951, amended 1971, 1981; and 338.400, RSMo 2011.