Bill Text: IA SF326 | 2017-2018 | 87th General Assembly | Introduced
Bill Title: A bill for an act relating to the prescribing of biological products and making penalties applicable. (Formerly SSB 1029.)
Sponsorship: Committee Bill
Status: (Introduced - Dead) 2017-03-01 - Withdrawn. S.J. 441. [SF326 Detail]
Download: Iowa-2017-SF326-Introduced.html
Senate File 326 - Introduced SENATE FILE BY COMMITTEE ON HUMAN RESOURCES (SUCCESSOR TO SSB 1029) A BILL FOR 1 An Act relating to the prescribing of biological products and 2 making penalties applicable. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: TLSB 1076SV (2) 87 tr/nh/rh PAG LIN 1 1 Section 1. Section 155A.3, Code 2017, is amended by adding 1 2 the following new subsections: 1 3 NEW SUBSECTION. 2A. "Biological product" means the same as 1 4 defined in 42 U.S.C. {262. 1 5 NEW SUBSECTION. 19A. "Interchangeable biological product" 1 6 means either of the following: 1 7 a. A biological product that the United States food and 1 8 drug administration has licensed and has determined meets 1 9 the standards for interchangeability pursuant to 42 U.S.C. 1 10 {262(k)(4). 1 11 b. A biological product that the United States food and 1 12 drug administration has determined to be therapeutically 1 13 equivalent to another biological product as set forth in the 1 14 latest edition or supplement of the United States food and 1 15 drug administration approved drug products with therapeutic 1 16 equivalence evaluations publication. 1 17 Sec. 2. Section 155A.28, Code 2017, is amended to read as 1 18 follows: 1 19 155A.28 Label of prescription drugs ==== interchangeable 1 20 biological product list. 1 21 1. The label of any drug, biological product, or device sold 1 22 and dispensed on the prescription of a practitioner shall be in 1 23 compliance with rules adopted by the board. 1 24 2. The board shall maintain a link on its internet site to 1 25 the current list of all biological products that the United 1 26 States food and drug administration has determined to be 1 27 interchangeable biological products. 1 28 Sec. 3. Section 155A.32, Code 2017, is amended to read as 1 29 follows: 1 30 155A.32 Drug product selection ==== restrictions. 1 31 1. a. If an authorized prescriber prescribes, in 1 32 writing, electronically, by facsimile, or orally, a drug 1 33 by its brand or trade name, the pharmacist may exercise 1 34 professional judgment in the economic interest of the patient 1 35 by selecting a drug product with the same generic name 2 1 and demonstrated bioavailability as theonedrug product 2 2 prescribed for dispensing and sale to the patient. If the 2 3 cost of the prescription or any part of it will be paid by 2 4 expenditure of public funds authorized under chapter 249A, the 2 5 pharmacist shall exercise professional judgment by selecting 2 6 a drug product with the same generic name and demonstrated 2 7 bioavailability as theonedrug product prescribed for 2 8 dispensing and sale.If the pharmacist exercises drug product 2 9 selection, the pharmacist shall inform the patient of the 2 10 savings which the patient will obtain as a result of the drug 2 11 product selection and pass on to the patient no less than fifty 2 12 percent of the difference in actual acquisition costs between 2 13 the drug prescribed and the drug substituted.2 14 b. If an authorized prescriber prescribes a biological 2 15 product, the pharmacist may exercise professional judgment in 2 16 the economic interest of the patient by selecting a biological 2 17 product that is an interchangeable biological product for the 2 18 biological product prescribed for dispensing and sale to the 2 19 patient. If the cost of the prescription or any part of it will 2 20 be paid by expenditure of public funds authorized under chapter 2 21 249A, the pharmacist shall exercise professional judgment by 2 22 selecting a biological product that is an interchangeable 2 23 biological product for the biological product prescribed for 2 24 dispensing and sale. 2 25 2. The pharmacist shall not exercise the drug or biological 2 26 product selection described in this section ifeitherany of 2 27 the following is true: 2 28 a. The prescriber specifically indicates that no drug or 2 29 biological product selection shall be made. 2 30 b. The person presenting the prescription indicates that 2 31 only the specific drug product prescribed should be dispensed. 2 32 However, this paragraph does not apply if the cost of the 2 33 prescription or any part of it will be paid by expenditure of 2 34 public funds authorized under chapter 249A. 2 35 3. If selection of a generically equivalent drug product 3 1 or an interchangeable biological product is made under this 3 2 section, the pharmacist making the selection shall inform the 3 3 patient and note that fact and the name of the manufacturer of 3 4 the selected drug on the prescription presented by the patient 3 5 or the patient's adult representative or transmitted by the 3 6 prescriber or the prescriber's authorized agent. 3 7 4. a. Within five business days following the dispensing 3 8 of a biological product, the dispensing pharmacist or the 3 9 pharmacist's designee shall make an entry of the specific 3 10 biological product provided to the patient, including the name 3 11 of the biological product and the manufacturer. The entry 3 12 shall be electronically accessible to the prescriber through 3 13 one of the following means: 3 14 (1) An interoperable electronic medical records system. 3 15 (2) An electronic prescribing technology. 3 16 (3) A pharmacy benefit management system. 3 17 (4) A pharmacy record. 3 18 b. An entry into an electronic records system as described 3 19 in this subsection is presumed to provide notice to the 3 20 prescriber. If the entry is not made electronically, the 3 21 pharmacist shall communicate the name and manufacturer of the 3 22 biological product dispensed to the prescriber using facsimile, 3 23 telephone, electronic transmission, or other prevailing means. 3 24 c. Communication under this subsection shall not be required 3 25 in either of the following circumstances: 3 26 (1) There is no federal food and drug 3 27 administration=approved interchangeable biological product for 3 28 the product prescribed. 3 29 (2) A refill prescription is not changed from the product 3 30 dispensed on the prior filling of the prescription. 3 31 EXPLANATION 3 32 The inclusion of this explanation does not constitute agreement with 3 33 the explanation's substance by the members of the general assembly. 3 34 This bill adopts by reference to federal law a definition of 3 35 "biological product" and defines "interchangeable biological 4 1 product". As described by the United States food and drug 4 2 administration, a "biological product" is a medical product, 4 3 often made from a variety of natural sources, used for a broad 4 4 range of diseases or conditions, particularly chronic, serious, 4 5 or life=threatening conditions such as cancer and rheumatoid 4 6 arthritis. 4 7 The bill provides that pharmacists may use professional 4 8 judgment to distribute an interchangeable biological product 4 9 when an authorized prescriber prescribes a biological product. 4 10 The bill requires the board of pharmacy to maintain a link 4 11 on its internet site to the current list of all biological 4 12 products that the United States food and drug administration 4 13 has determined to be interchangeable biological products. 4 14 The bill provides that a pharmacist may not dispense 4 15 an interchangeable biological product if the prescriber 4 16 specifically indicates that no product selection shall be made 4 17 or the person presenting the prescription indicates that only 4 18 the specific biological product prescribed should be dispensed. 4 19 The bill removes a provision that requires a pharmacist 4 20 to pass on to the patient no less than 50 percent of the 4 21 difference in actual acquisition costs between the drug 4 22 prescribed and the drug substituted and inform a patient of 4 23 those savings if the pharmacist makes a drug product selection. 4 24 The bill requires a pharmacist to notify a patient whenever 4 25 the pharmacist selects a generically equivalent drug product or 4 26 an interchangeable biological product. 4 27 The bill requires that within five days of dispensing an 4 28 interchangeable biological product, a pharmacist must make 4 29 an entry into one of a specified type of electronic records 4 30 systems noting the name and manufacturer of the biological 4 31 product. According to the bill, such an entry is deemed to 4 32 provide notice to the prescriber if done electronically. If 4 33 it is not done electronically, the pharmacist must otherwise 4 34 provide the name and manufacturer of the biological product to 4 35 the prescriber. Such communication is not required if a refill 5 1 prescription is not changed from the product dispensed on the 5 2 prior filling of the prescription. 5 3 A person who violates these provisions with regard to 5 4 a noncontrolled substance shall be guilty of a serious 5 5 misdemeanor for a first violation, an aggravated misdemeanor 5 6 for a second offense or if the person has been convicted with 5 7 a violation of laws relating to prescription drugs or devices 5 8 in other jurisdictions, or a class "D" felony for a third 5 9 offense or a second offense with prior conviction in another 5 10 jurisdiction. A person who violates these provisions with 5 11 regard to a controlled substance shall be punished pursuant to 5 12 Code section 124.401, subsection 1, and other provisions of 5 13 Code chapter 124, division IV. LSB 1076SV (2) 87 tr/nh/rh
