Senate Study Bill 1073 - Introduced SENATE/HOUSE FILE _____ BY (PROPOSED BOARD OF PHARMACY BILL) A BILL FOR An Act relating to the Iowa prescription monitoring program and 1 making penalties applicable. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 1267DP (2) 87 tr/nh/rh
S.F. _____ H.F. _____ Section 1. Section 124.551, subsection 2, Code 2017, is 1 amended to read as follows: 2 2. The program shall collect from pharmacies dispensing 3 information for controlled substances identified pursuant to 4 section 124.554, subsection 1 , paragraph “g” . The information 5 collected shall be used by prescribing practitioners and 6 pharmacists on a need-to-know basis for purposes of improving 7 patient health care by facilitating early identification of 8 patients who may be at risk for addiction, or who may be using, 9 abusing, or diverting drugs controlled substances for unlawful 10 or otherwise unauthorized purposes at risk to themselves and 11 others, or who may be appropriately using controlled substances 12 lawfully prescribed for them but unknown to the practitioner. 13 Sec. 2. Section 124.552, subsection 1, unnumbered paragraph 14 1, Code 2017, is amended to read as follows: 15 Each Unless otherwise prohibited by federal or state law, 16 each licensed pharmacy that dispenses controlled substances 17 identified pursuant to section 124.554, subsection 1 , paragraph 18 “g” , to patients in the state , and ; each licensed pharmacy 19 located in the state that dispenses such controlled substances 20 identified pursuant to section 124.554, subsection 1 , 21 paragraph “g” , to patients inside or outside the state, unless 22 specifically excepted in this section or by rule , ; and each 23 prescribing practitioner furnishing, dispensing, or supplying 24 controlled substances to the prescribing practitioner’s 25 patient, shall submit the following prescription information 26 to the program: 27 Sec. 3. Section 124.552, subsection 1, paragraph a, Code 28 2017, is amended to read as follows: 29 a. Pharmacy identification , if applicable . 30 Sec. 4. Section 124.552, subsections 3 and 4, Code 2017, are 31 amended to read as follows: 32 3. Information shall be timely transmitted as designated by 33 the board and advisory council by rule, unless the board grants 34 an extension. The board may grant an extension if either of 35 -1- LSB 1267DP (2) 87 tr/nh/rh 1/ 7
S.F. _____ H.F. _____ the following occurs: 1 a. The pharmacy or prescribing practitioner suffers 2 a mechanical or electronic failure, or cannot meet the 3 deadline established by the board for other reasons beyond the 4 pharmacy’s or prescribing practitioner’s control. 5 b. The board is unable to receive electronic submissions. 6 4. This section shall not apply to a prescribing 7 practitioner furnishing, dispensing, supplying, or 8 administering drugs to the prescribing practitioner’s patient, 9 or to dispensing by a licensed pharmacy for the purposes of 10 inpatient hospital care, inpatient hospice care, or long-term 11 residential facility patient care. 12 Sec. 5. Section 124.553, subsection 1, Code 2017, is amended 13 by adding the following new paragraph: 14 NEW PARAGRAPH . f. By targeted distribution of unsolicited 15 reports, a prescribing practitioner or pharmacist who has been 16 involved in authorizing or dispensing controlled substances 17 to a patient who has been identified by the board, based on 18 thresholds or criteria established by the board by rule, as 19 an at-risk patient who may be abusing or misusing controlled 20 substances or who may be in jeopardy of overdose or addiction 21 to controlled substances. 22 Sec. 6. Section 124.553, subsections 2, 3, and 8, Code 2017, 23 are amended to read as follows: 24 2. The board shall maintain a record of each person that 25 requests information from the program and of all unsolicited 26 reports distributed as provided in subsection 1, paragraph 27 “f” . Pursuant to rules adopted by the board and advisory 28 council under section 124.554 , the board may use the records 29 to document and report statistical information, and may 30 provide program information for statistical, public research, 31 public policy, or educational purposes, after removing 32 personal identifying information of a patient, prescribing 33 practitioner, dispenser, or other person who is identified in 34 the information. 35 -2- LSB 1267DP (2) 87 tr/nh/rh 2/ 7
S.F. _____ H.F. _____ 3. Information contained in the program and any information 1 obtained from it, and information contained in the records of 2 requests for information from the program and of unsolicited 3 reports distributed to prescribing practitioners and 4 dispensing pharmacists , is privileged and strictly confidential 5 information. Such information is a confidential public record 6 pursuant to section 22.7 , and is not subject to discovery, 7 subpoena, or other means of legal compulsion for release except 8 as provided in this division . Information from the program 9 shall not be released, shared with an agency or institution, or 10 made public except as provided in this division . 11 8. The board may enter into an agreement with a prescription 12 database or monitoring program operated in a state bordering 13 this state or in the state of Kansas any state for the mutual 14 exchange of information. Any agreement entered into pursuant 15 to this subsection shall specify that all the information 16 exchanged pursuant to the agreement shall be used and 17 disseminated in accordance with the laws of this state. 18 Sec. 7. Section 124.554, Code 2017, is amended to read as 19 follows: 20 124.554 Rules and reporting. 21 1. The board and advisory council shall jointly adopt 22 rules in accordance with chapter 17A to carry out the purposes 23 of, and to enforce the provisions of, this division . The 24 rules shall include but not be limited to the development of 25 procedures relating to: 26 a. Identifying each patient about whom information is 27 entered into the program. 28 b. An electronic format for the submission of information 29 from pharmacies and prescribing practitioners . 30 c. A waiver to submit information in another format for 31 a pharmacy or prescribing practitioner unable to submit 32 information electronically. 33 d. An application by a pharmacy or prescribing practitioner 34 for an extension of time for transmitting information to the 35 -3- LSB 1267DP (2) 87 tr/nh/rh 3/ 7
S.F. _____ H.F. _____ program. 1 e. The submission by an authorized requestor of a request 2 for information and a procedure for the verification of the 3 identity of the requestor. 4 f. Use by the board or advisory council of the program 5 request records required by section 124.553, subsection 2 , to 6 document and report statistical information. 7 g. Including all schedule II , schedule III, and schedule 8 IV controlled substances and those substances in schedules 9 III and IV that the advisory council and board determine can 10 be addictive or fatal if not taken under the proper care and 11 direction of a prescribing practitioner schedule V controlled 12 substances except when dispensed by a pharmacist without a 13 prescription . 14 h. Access by a pharmacist or prescribing practitioner to 15 information in the program pursuant to a written agreement with 16 the board and advisory council . 17 i. The correction or deletion of erroneous information in 18 the program. 19 j. The establishment of thresholds or other criteria or 20 measures to be used in identifying an at-risk patient as 21 provided in section 124.553, subsection 1, paragraph “f” , and 22 the targeted distribution of unsolicited reports suggesting 23 review of the patient’s prescription history. 24 2. Beginning January 1, 2007 15, 2018 , and annually by 25 January 1 15 thereafter, the board and advisory council shall 26 present to the general assembly and the governor a report 27 prepared consistent with section 124.555, subsection 3 , 28 paragraph “d” , which shall include but not be limited to the 29 following: 30 a. The cost to the state of implementing and maintaining the 31 program. 32 b. Information from pharmacies, prescribing practitioners, 33 the board, the advisory council, and others regarding the 34 benefits or detriments of the program. 35 -4- LSB 1267DP (2) 87 tr/nh/rh 4/ 7
S.F. _____ H.F. _____ c. Information from pharmacies, prescribing practitioners, 1 the board, the advisory council, and others regarding the 2 board’s effectiveness in providing information from the 3 program. 4 Sec. 8. Section 124.555, subsection 2, Code 2017, is amended 5 to read as follows: 6 2. The council shall advance the goals of the program, 7 which include identification of misuse and diversion of 8 controlled substances identified pursuant to section 124.554, 9 subsection 1 , paragraph “g” , reduction of drug overdoses and 10 deaths attributable to prescription drug use and abuse, and 11 enhancement of the quality of health care delivery in this 12 state. 13 Sec. 9. Section 124.558, subsection 1, Code 2017, is amended 14 to read as follows: 15 1. Failure to comply with requirements. A pharmacist, 16 pharmacy, prescribing practitioner, or agent of a pharmacist or 17 prescribing practitioner who knowingly fails to comply with the 18 confidentiality requirements of this division or who delegates 19 program information access to another individual except as 20 provided in section 124.553 , is subject to disciplinary action 21 by the appropriate professional licensing board. A prescribing 22 practitioner, pharmacist , or pharmacy that knowingly fails to 23 comply with other requirements of this division is subject to 24 disciplinary action by the board. Each licensing board may 25 adopt rules in accordance with chapter 17A to implement the 26 provisions of this section . 27 EXPLANATION 28 The inclusion of this explanation does not constitute agreement with 29 the explanation’s substance by the members of the general assembly. 30 This bill adds dispensing prescribers, unless otherwise 31 prohibited by federal or state law, to those persons required 32 to submit to the Iowa prescription monitoring program any 33 reportable controlled substances dispensed or distributed to 34 patients in this state. Dispensing prescribers are added 35 -5- LSB 1267DP (2) 87 tr/nh/rh 5/ 7
S.F. _____ H.F. _____ to respective Code provisions relating to extensions of 1 time to submit required records, the required form of record 2 submission, and penalties for failing to submit required 3 records to the Iowa prescription monitoring program. 4 The bill authorizes the board of pharmacy and the Iowa 5 prescription monitoring program advisory council to establish 6 criteria for the identification of patients whose use of 7 controlled substances may raise concerns about the safety of 8 the patients’ drug regimens and use patterns for the purpose 9 of communicating those concerns with the prescribers and 10 pharmacists involved in the patients’ care. 11 The bill permits the board to interconnect with any other 12 state prescription monitoring program for the sharing of 13 patient prescription records on the condition that the other 14 state prescription monitoring program agrees to comply with 15 the laws and rules of this state regarding the access to, 16 distribution of, and use of Iowa prescription monitoring 17 program information and data. The bill also authorizes the 18 collection of dispensing records for all schedule II, III, 19 IV, and V controlled substances except when the schedule V 20 controlled substance is dispensed by a pharmacist without a 21 prescription. 22 The bill adds to the goals of the program the reduction of 23 overdoses and deaths as a result of prescription controlled 24 substance use and abuse. The bill changes the due date for 25 annual reports to the governor and the legislature regarding 26 the program from January 1 to January 15. 27 A pharmacist, pharmacy, prescribing practitioner, or agent 28 of a pharmacist or prescribing practitioner who knowingly fails 29 to comply with the confidentiality requirements of the bill or 30 who delegates program information access to another individual 31 except as provided in Code section 124.553 is subject to 32 disciplinary action by the appropriate professional licensing 33 board. A pharmacist or pharmacy that knowingly fails to comply 34 with other requirements of the bill is subject to disciplinary 35 -6- LSB 1267DP (2) 87 tr/nh/rh 6/ 7
S.F. _____ H.F. _____ action by the board. A person who intentionally or knowingly 1 accesses, uses, or discloses program information in violation 2 of the bill, unless otherwise authorized by law, is guilty of a 3 class “D” felony. 4 -7- LSB 1267DP (2) 87 tr/nh/rh 7/ 7