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1 | | "Opioid" means a narcotic drug or substance that is a |
2 | | Schedule II controlled substance under paragraph (1), (2), |
3 | | (3), or (5) of subsection (b) or under subsection (c) of |
4 | | Section 206. |
5 | | (b) Decisions regarding the treatment of patients |
6 | | experiencing chronic pain shall be made by the prescriber with |
7 | | dispensing by the pharmacist in accordance with the |
8 | | corresponding responsibility as described in 21 CFR 1306.04(a) |
9 | | and 77 Ill. Adm. Code 3100.380(a). |
10 | | (c) Ordering, prescribing, dispensing, administering, or |
11 | | paying for controlled substances, including opioids, shall not |
12 | | in any way be predetermined by specific morphine milligram |
13 | | equivalent guidelines except as provided under federal law. |
14 | | (d) Nothing in this Section shall interfere with the |
15 | | review of prescriptions by the Prescription Monitoring |
16 | | Program's Peer Review Committee. In reviewing prescriptions |
17 | | for chronic pain, the peer review committee members shall |
18 | | review the most updated clinical guidelines on treating |
19 | | chronic pain for the period the prescriptions were written. |
20 | | (720 ILCS 570/318) |
21 | | (Text of Section before amendment by P.A. 103-881 ) |
22 | | Sec. 318. Confidentiality of information. |
23 | | (a) Information received by the central repository under |
24 | | Section 316 and former Section 321 is confidential. |
25 | | (a-1) To ensure the federal Health Insurance Portability |
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1 | | and Accountability Act and confidentiality of substance use |
2 | | disorder patient records rules that mandate the privacy of an |
3 | | individual's prescription data reported to the Prescription |
4 | | Monitoring Program received from a retail dispenser under this |
5 | | Act, and in order to execute the duties and responsibilities |
6 | | under Section 316 of this Act and rules for disclosure under |
7 | | this Section, the Clinical Director of the Prescription |
8 | | Monitoring Program or his or her designee shall maintain |
9 | | direct access to all Prescription Monitoring Program data. Any |
10 | | request for Prescription Monitoring Program data from any |
11 | | other department or agency must be approved in writing by the |
12 | | Clinical Director of the Prescription Monitoring Program or |
13 | | his or her designee unless otherwise permitted by law. |
14 | | Prescription Monitoring Program data shall only be disclosed |
15 | | as permitted by law. Confidential information received from |
16 | | opioid treatment programs or confidential information |
17 | | otherwise protected under federal confidentiality of substance |
18 | | use disorder patient records regulations under 42 CFR Part 2 |
19 | | shall not be included in the information shared. |
20 | | (a-2) As an active step to address the current opioid |
21 | | crisis in this State and to prevent and reduce addiction |
22 | | resulting from a sports injury or an accident, the |
23 | | Prescription Monitoring Program and the Department of Public |
24 | | Health shall coordinate a continuous review of the |
25 | | Prescription Monitoring Program and the Department of Public |
26 | | Health data to determine if a patient may be at risk of opioid |
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1 | | addiction. Each patient discharged from any medical facility |
2 | | with an International Classification of Disease, 10th edition |
3 | | code related to a sport or accident injury shall be subject to |
4 | | the data review. If the discharged patient is dispensed a |
5 | | controlled substance, the Prescription Monitoring Program |
6 | | shall alert the patient's prescriber as to the addiction risk |
7 | | and urge each to follow the Centers for Disease Control and |
8 | | Prevention guidelines or his or her respective profession's |
9 | | treatment guidelines related to the patient's injury. This |
10 | | subsection (a-2), other than this sentence, is inoperative on |
11 | | or after January 1, 2024. |
12 | | (b) The Department must carry out a program to protect the |
13 | | confidentiality of the information described in subsection |
14 | | (a). The Department may disclose the information to another |
15 | | person only under subsection (c), (d), or (f) and may charge a |
16 | | fee not to exceed the actual cost of furnishing the |
17 | | information. |
18 | | (c) The Department may disclose confidential information |
19 | | described in subsection (a) to any person who is engaged in |
20 | | receiving, processing, or storing the information. |
21 | | (d) The Department may release confidential information |
22 | | described in subsection (a) to the following persons: |
23 | | (1) A governing body that licenses practitioners and |
24 | | is engaged in an investigation, an adjudication, or a |
25 | | prosecution of a violation under any State or federal law |
26 | | that involves a controlled substance. |
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1 | | (2) An investigator for the Consumer Protection |
2 | | Division of the office of the Attorney General, a |
3 | | prosecuting attorney, the Attorney General, a deputy |
4 | | Attorney General, or an investigator from the office of |
5 | | the Attorney General, who is engaged in any of the |
6 | | following activities involving controlled substances: |
7 | | (A) an investigation; |
8 | | (B) an adjudication; or |
9 | | (C) a prosecution of a violation under any State |
10 | | or federal law that involves a controlled substance. |
11 | | (3) A law enforcement officer who is: |
12 | | (A) authorized by the Illinois State Police or the |
13 | | office of a county sheriff or State's Attorney or |
14 | | municipal police department of Illinois to receive |
15 | | information of the type requested for the purpose of |
16 | | investigations involving controlled substances; or |
17 | | (B) approved by the Department to receive |
18 | | information of the type requested for the purpose of |
19 | | investigations involving controlled substances; and |
20 | | (C) engaged in the investigation or prosecution of |
21 | | a violation under any State or federal law that |
22 | | involves a controlled substance. |
23 | | (4) Select representatives of the Department of |
24 | | Children and Family Services through the indirect online |
25 | | request process. Access shall be established by an |
26 | | intergovernmental agreement between the Department of |
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1 | | Children and Family Services and the Department of Human |
2 | | Services. |
3 | | (e) Before the Department releases confidential |
4 | | information under subsection (d), all of the following must be |
5 | | demonstrated the applicant must demonstrate in writing to the |
6 | | Department by the applicant that : |
7 | | (1) the applicant has reason to believe that a |
8 | | violation under any State or federal law that involves a |
9 | | controlled substance has occurred; and |
10 | | (2) the requested information is reasonably related to |
11 | | the investigation, adjudication, or prosecution of the |
12 | | violation described in subdivision (1) ; and . |
13 | | (3) the applicant has a valid court order or subpoena, |
14 | | or an administrative subpoena issued by the Department of |
15 | | Financial and Professional Regulation, for the |
16 | | confidential information requested. |
17 | | (f) The Department may receive and release confidential |
18 | | prescription record information collected under Sections 316 |
19 | | and 321 (now repealed) that identifies vendors or |
20 | | practitioners, or both, who are prescribing or dispensing |
21 | | large quantities of Schedule II, III, IV, or V controlled |
22 | | substances outside the scope of their practice, pharmacy, or |
23 | | business, as determined by the Advisory Committee created by |
24 | | Section 320, prescription record information under Section 316 |
25 | | and former Section 321 to: |
26 | | (1) a governing body that licenses practitioners; |
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1 | | (2) an investigator for the Consumer Protection |
2 | | Division of the office of the Attorney General, a |
3 | | prosecuting attorney, the Attorney General, a deputy |
4 | | Attorney General, or an investigator from the office of |
5 | | the Attorney General; |
6 | | (3) any Illinois law enforcement officer who is: |
7 | | (A) authorized to receive the type of information |
8 | | released; and |
9 | | (B) approved by the Department to receive the type |
10 | | of information released; or |
11 | | (4) prescription monitoring entities in other states |
12 | | per the provisions outlined in subsection (g) and (h) |
13 | | below . ; |
14 | | confidential prescription record information collected under |
15 | | Sections 316 and 321 (now repealed) that identifies vendors or |
16 | | practitioners, or both, who are prescribing or dispensing |
17 | | large quantities of Schedule II, III, IV, or V controlled |
18 | | substances outside the scope of their practice, pharmacy, or |
19 | | business, as determined by the Advisory Committee created by |
20 | | Section 320. |
21 | | (f-5) In accordance with a confidentiality agreement |
22 | | entered into with the Department, a medical director, or a |
23 | | public health administrator and their delegated analysts, of a |
24 | | county or municipal health department or the Department of |
25 | | Public Health shall have access to data from the system for any |
26 | | of the following purposes: |
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1 | | (1) developing education programs or public health |
2 | | interventions relating to prescribing trends and |
3 | | controlled substance use; or |
4 | | (2) conducting analyses and publish reports on |
5 | | prescribing trends in their respective jurisdictions. |
6 | | At a minimum, the confidentiality agreement entered into |
7 | | with the Department shall: |
8 | | (i) prohibit analysis and reports produced under |
9 | | subparagraph (2) from including information that |
10 | | identifies, by name, license, or address, any |
11 | | practitioner, dispenser, ultimate user, or other person |
12 | | administering a controlled substance; and |
13 | | (ii) specify the appropriate technical and physical |
14 | | safeguards that the county or municipal health department |
15 | | must implement to ensure the privacy and security of data |
16 | | obtained from the system. The data from the system shall |
17 | | not be admissible as evidence, nor discoverable in any |
18 | | action of any kind in any court or before any tribunal, |
19 | | board, agency, or person. The disclosure of any such |
20 | | information or data, whether proper or improper, shall not |
21 | | waive or have any effect upon its confidentiality, |
22 | | non-discoverability, or non-admissibility. |
23 | | (g) The information described in subsection (f) may not be |
24 | | released until it has been reviewed by an employee of the |
25 | | Department who is licensed as a prescriber or a dispenser and |
26 | | until that employee has certified that further investigation |
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1 | | is warranted. Upon review and approval by a licensed |
2 | | prescriber or dispenser, or trained designee, the Prescription |
3 | | Monitoring Program may release information described in |
4 | | subsection (f). However, failure to comply with this |
5 | | subsection (g) does not invalidate the use of any evidence |
6 | | that is otherwise admissible in a proceeding described in |
7 | | subsection (h). |
8 | | (h) An investigator or a law enforcement officer receiving |
9 | | confidential information under subsection (c), (d), or (f) may |
10 | | disclose the information to a law enforcement officer or an |
11 | | attorney for the office of the Attorney General for use as |
12 | | evidence in the following: |
13 | | (1) A proceeding under any State or federal law that |
14 | | involves a controlled substance. |
15 | | (2) A criminal proceeding or a proceeding in juvenile |
16 | | court that involves a controlled substance. |
17 | | (i) The Department may compile statistical reports from |
18 | | the information described in subsection (a). The reports must |
19 | | not include information that identifies, by name, license or |
20 | | address, any practitioner, dispenser, ultimate user, or other |
21 | | person administering a controlled substance. |
22 | | (j) Based upon federal, initial and maintenance funding, a |
23 | | prescriber and dispenser inquiry system shall be developed to |
24 | | assist the health care community in its goal of effective |
25 | | clinical practice and to prevent patients from diverting or |
26 | | abusing medications. |
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1 | | (1) An inquirer shall have read-only access to a |
2 | | stand-alone database which shall contain records for the |
3 | | previous 12 months. |
4 | | (2) Dispensers may, upon positive and secure |
5 | | identification, make an inquiry on a patient or customer |
6 | | solely for a medical purpose as delineated within the |
7 | | federal HIPAA law. |
8 | | (3) The Department shall provide a one-to-one secure |
9 | | link and encrypted software necessary to establish the |
10 | | link between an inquirer and the Department. Technical |
11 | | assistance shall also be provided. |
12 | | (4) Written inquiries are acceptable but must include |
13 | | the fee and the requester's Drug Enforcement |
14 | | Administration license number and submitted upon the |
15 | | requester's business stationery. |
16 | | (5) As directed by the Prescription Monitoring Program |
17 | | Advisory Committee and the Clinical Director for the |
18 | | Prescription Monitoring Program, aggregate data that does |
19 | | not indicate any prescriber, practitioner, dispenser, or |
20 | | patient may be used for clinical studies. |
21 | | (6) Tracking analysis shall be established and used |
22 | | per administrative rule. |
23 | | (7) Nothing in this Act or Illinois law shall be |
24 | | construed to require a prescriber or dispenser to make use |
25 | | of this inquiry system. |
26 | | (8) If there is an adverse outcome because of a |
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1 | | prescriber or dispenser making an inquiry, which is |
2 | | initiated in good faith, the prescriber or dispenser shall |
3 | | be held harmless from any civil liability. |
4 | | (k) The Department shall establish, by rule, the process |
5 | | by which to evaluate possible erroneous association of |
6 | | prescriptions to any licensed prescriber or end user of the |
7 | | Illinois Prescription Information Library (PIL). |
8 | | (l) The Prescription Monitoring Program Advisory Committee |
9 | | is authorized to evaluate the need for and method of |
10 | | establishing a patient specific identifier. |
11 | | (m) Patients who identify prescriptions attributed to them |
12 | | that were not obtained by them shall be given access to their |
13 | | personal prescription history pursuant to the validation |
14 | | process as set forth by administrative rule. |
15 | | (n) The Prescription Monitoring Program is authorized to |
16 | | develop operational push reports to entities with compatible |
17 | | electronic medical records. The process shall be covered |
18 | | within administrative rule established by the Department. |
19 | | (o) Hospital emergency departments and freestanding |
20 | | healthcare facilities providing healthcare to walk-in patients |
21 | | may obtain, for the purpose of improving patient care, a |
22 | | unique identifier for each shift to utilize the PIL system. |
23 | | (p) The Prescription Monitoring Program shall |
24 | | automatically create a log-in to the inquiry system when a |
25 | | prescriber or dispenser obtains or renews his or her |
26 | | controlled substance license. The Department of Financial and |
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1 | | Professional Regulation must provide the Prescription |
2 | | Monitoring Program with electronic access to the license |
3 | | information of a prescriber or dispenser to facilitate the |
4 | | creation of this profile. The Prescription Monitoring Program |
5 | | shall send the prescriber or dispenser information regarding |
6 | | the inquiry system, including instructions on how to log into |
7 | | the system, instructions on how to use the system to promote |
8 | | effective clinical practice, and opportunities for continuing |
9 | | education for the prescribing of controlled substances. The |
10 | | Prescription Monitoring Program shall also send to all |
11 | | enrolled prescribers, dispensers, and designees information |
12 | | regarding the unsolicited reports produced pursuant to Section |
13 | | 314.5 of this Act. |
14 | | (q) A prescriber or dispenser may authorize a designee to |
15 | | consult the inquiry system established by the Department under |
16 | | this subsection on his or her behalf, provided that all the |
17 | | following conditions are met: |
18 | | (1) the designee so authorized is employed by the same |
19 | | hospital or health care system; is employed by the same |
20 | | professional practice; or is under contract with such |
21 | | practice, hospital, or health care system; |
22 | | (2) the prescriber or dispenser takes reasonable steps |
23 | | to ensure that such designee is sufficiently competent in |
24 | | the use of the inquiry system; |
25 | | (3) the prescriber or dispenser remains responsible |
26 | | for ensuring that access to the inquiry system by the |
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1 | | designee is limited to authorized purposes and occurs in a |
2 | | manner that protects the confidentiality of the |
3 | | information obtained from the inquiry system, and remains |
4 | | responsible for any breach of confidentiality; and |
5 | | (4) the ultimate decision as to whether or not to |
6 | | prescribe or dispense a controlled substance remains with |
7 | | the prescriber or dispenser. |
8 | | The Prescription Monitoring Program shall send to |
9 | | registered designees information regarding the inquiry system, |
10 | | including instructions on how to log onto the system. |
11 | | (r) The Prescription Monitoring Program shall maintain an |
12 | | Internet website in conjunction with its prescriber and |
13 | | dispenser inquiry system. This website shall include, at a |
14 | | minimum, the following information: |
15 | | (1) current clinical guidelines developed by health |
16 | | care professional organizations on the prescribing of |
17 | | opioids or other controlled substances as determined by |
18 | | the Advisory Committee; |
19 | | (2) accredited continuing education programs related |
20 | | to prescribing of controlled substances; |
21 | | (3) programs or information developed by health care |
22 | | professionals that may be used to assess patients or help |
23 | | ensure compliance with prescriptions; |
24 | | (4) updates from the Food and Drug Administration, the |
25 | | Centers for Disease Control and Prevention, and other |
26 | | public and private organizations which are relevant to |
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1 | | prescribing; |
2 | | (5) relevant medical studies related to prescribing; |
3 | | (6) other information regarding the prescription of |
4 | | controlled substances; and |
5 | | (7) information regarding prescription drug disposal |
6 | | events, including take-back programs or other disposal |
7 | | options or events. |
8 | | The content of the Internet website shall be periodically |
9 | | reviewed by the Prescription Monitoring Program Advisory |
10 | | Committee as set forth in Section 320 and updated in |
11 | | accordance with the recommendation of the advisory committee. |
12 | | (s) The Prescription Monitoring Program shall regularly |
13 | | send electronic updates to the registered users of the |
14 | | Program. The Prescription Monitoring Program Advisory |
15 | | Committee shall review any communications sent to registered |
16 | | users and also make recommendations for communications as set |
17 | | forth in Section 320. These updates shall include the |
18 | | following information: |
19 | | (1) opportunities for accredited continuing education |
20 | | programs related to prescribing of controlled substances; |
21 | | (2) current clinical guidelines developed by health |
22 | | care professional organizations on the prescribing of |
23 | | opioids or other drugs as determined by the Advisory |
24 | | Committee; |
25 | | (3) programs or information developed by health care |
26 | | professionals that may be used to assess patients or help |
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1 | | ensure compliance with prescriptions; |
2 | | (4) updates from the Food and Drug Administration, the |
3 | | Centers for Disease Control and Prevention, and other |
4 | | public and private organizations which are relevant to |
5 | | prescribing; |
6 | | (5) relevant medical studies related to prescribing; |
7 | | (6) other information regarding prescribing of |
8 | | controlled substances; |
9 | | (7) information regarding prescription drug disposal |
10 | | events, including take-back programs or other disposal |
11 | | options or events; and |
12 | | (8) reminders that the Prescription Monitoring Program |
13 | | is a useful clinical tool. |
14 | | (t) Notwithstanding any other provision of this Act, |
15 | | neither the Prescription Monitoring Program nor any other |
16 | | person shall disclose any information in violation of the |
17 | | restrictions and requirements of paragraph (3.5) of subsection |
18 | | (a) of Section 316 as implemented under Public Act 102-527. |
19 | | (Source: P.A. 102-751, eff. 1-1-23 .) |
20 | | (Text of Section after amendment by P.A. 103-881 ) |
21 | | Sec. 318. Confidentiality of information. |
22 | | (a) Information received by the central repository under |
23 | | Section 316 and former Section 321 is confidential. |
24 | | (a-1) To ensure the federal Health Insurance Portability |
25 | | and Accountability Act and confidentiality of substance use |
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1 | | disorder patient records rules that mandate the privacy of an |
2 | | individual's prescription data reported to the Prescription |
3 | | Monitoring Program received from a retail dispenser under this |
4 | | Act, and in order to execute the duties and responsibilities |
5 | | under Section 316 of this Act and rules for disclosure under |
6 | | this Section, the Clinical Director of the Prescription |
7 | | Monitoring Program or his or her designee shall maintain |
8 | | direct access to all Prescription Monitoring Program data. Any |
9 | | request for Prescription Monitoring Program data from any |
10 | | other department or agency must be approved in writing by the |
11 | | Clinical Director of the Prescription Monitoring Program or |
12 | | his or her designee unless otherwise permitted by law. |
13 | | Prescription Monitoring Program data shall only be disclosed |
14 | | as permitted by law. Confidential information received from |
15 | | opioid treatment programs or confidential information |
16 | | otherwise protected under federal confidentiality of substance |
17 | | use disorder patient records regulations under 42 CFR Part 2 |
18 | | shall not be included in the information shared. |
19 | | (a-2) As an active step to address the current opioid |
20 | | crisis in this State and to prevent and reduce substance use |
21 | | disorders resulting from a sports injury or an accident, the |
22 | | Prescription Monitoring Program and the Department of Public |
23 | | Health shall coordinate a continuous review of the |
24 | | Prescription Monitoring Program and the Department of Public |
25 | | Health data to determine if a patient may be at risk of opioid |
26 | | use disorder. Each patient discharged from any medical |
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1 | | facility with an International Classification of Disease, 10th |
2 | | edition code related to a sport or accident injury shall be |
3 | | subject to the data review. If the discharged patient is |
4 | | dispensed a controlled substance, the Prescription Monitoring |
5 | | Program shall alert the patient's prescriber as to the risk of |
6 | | developing a substance use disorder and urge each to follow |
7 | | the Centers for Disease Control and Prevention guidelines or |
8 | | his or her respective profession's treatment guidelines |
9 | | related to the patient's injury. This subsection (a-2), other |
10 | | than this sentence, is inoperative on or after January 1, |
11 | | 2024. |
12 | | (b) The Department must carry out a program to protect the |
13 | | confidentiality of the information described in subsection |
14 | | (a). The Department may disclose the information to another |
15 | | person only under subsection (c), (d), or (f) and may charge a |
16 | | fee not to exceed the actual cost of furnishing the |
17 | | information. |
18 | | (c) The Department may disclose confidential information |
19 | | described in subsection (a) to any person who is engaged in |
20 | | receiving, processing, or storing the information. |
21 | | (d) The Department may release confidential information |
22 | | described in subsection (a) to the following persons: |
23 | | (1) A governing body that licenses practitioners and |
24 | | is engaged in an investigation, an adjudication, or a |
25 | | prosecution of a violation under any State or federal law |
26 | | that involves a controlled substance. |
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1 | | (2) An investigator for the Consumer Protection |
2 | | Division of the office of the Attorney General, a |
3 | | prosecuting attorney, the Attorney General, a deputy |
4 | | Attorney General, or an investigator from the office of |
5 | | the Attorney General, who is engaged in any of the |
6 | | following activities involving controlled substances: |
7 | | (A) an investigation; |
8 | | (B) an adjudication; or |
9 | | (C) a prosecution of a violation under any State |
10 | | or federal law that involves a controlled substance. |
11 | | (3) A law enforcement officer who is: |
12 | | (A) authorized by the Illinois State Police or the |
13 | | office of a county sheriff or State's Attorney or |
14 | | municipal police department of Illinois to receive |
15 | | information of the type requested for the purpose of |
16 | | investigations involving controlled substances; or |
17 | | (B) approved by the Department to receive |
18 | | information of the type requested for the purpose of |
19 | | investigations involving controlled substances; and |
20 | | (C) engaged in the investigation or prosecution of |
21 | | a violation under any State or federal law that |
22 | | involves a controlled substance. |
23 | | (4) Select representatives of the Department of |
24 | | Children and Family Services through the indirect online |
25 | | request process. Access shall be established by an |
26 | | intergovernmental agreement between the Department of |
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1 | | Children and Family Services and the Department of Human |
2 | | Services. |
3 | | (e) Before the Department releases confidential |
4 | | information under subsection (d), all of the following must be |
5 | | demonstrated the applicant must demonstrate in writing to the |
6 | | Department by the applicant that : |
7 | | (1) the applicant has reason to believe that a |
8 | | violation under any State or federal law that involves a |
9 | | controlled substance has occurred; and |
10 | | (2) the requested information is reasonably related to |
11 | | the investigation, adjudication, or prosecution of the |
12 | | violation described in subdivision (1) ; and . |
13 | | (3) the applicant has a valid court order or subpoena, |
14 | | or an administrative subpoena issued by the Department of |
15 | | Financial and Professional Regulation, for the |
16 | | confidential information requested. |
17 | | (f) The Department may receive and release confidential |
18 | | prescription record information collected under Sections 316 |
19 | | and 321 (now repealed) that identifies vendors or |
20 | | practitioners, or both, who are prescribing or dispensing |
21 | | large quantities of Schedule II, III, IV, or V controlled |
22 | | substances outside the scope of their practice, pharmacy, or |
23 | | business, as determined by the Advisory Committee created by |
24 | | Section 320, prescription record information under Section 316 |
25 | | and former Section 321 to: |
26 | | (1) a governing body that licenses practitioners; |
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1 | | (2) an investigator for the Consumer Protection |
2 | | Division of the office of the Attorney General, a |
3 | | prosecuting attorney, the Attorney General, a deputy |
4 | | Attorney General, or an investigator from the office of |
5 | | the Attorney General; |
6 | | (3) any Illinois law enforcement officer who is: |
7 | | (A) authorized to receive the type of information |
8 | | released; and |
9 | | (B) approved by the Department to receive the type |
10 | | of information released; or |
11 | | (4) prescription monitoring entities in other states |
12 | | per the provisions outlined in subsection (g) and (h) |
13 | | below . ; |
14 | | confidential prescription record information collected under |
15 | | Sections 316 and 321 (now repealed) that identifies vendors or |
16 | | practitioners, or both, who are prescribing or dispensing |
17 | | large quantities of Schedule II, III, IV, or V controlled |
18 | | substances outside the scope of their practice, pharmacy, or |
19 | | business, as determined by the Advisory Committee created by |
20 | | Section 320. |
21 | | (f-5) In accordance with a confidentiality agreement |
22 | | entered into with the Department, a medical director, or a |
23 | | public health administrator and their delegated analysts, of a |
24 | | county or municipal health department or the Department of |
25 | | Public Health shall have access to data from the system for any |
26 | | of the following purposes: |
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1 | | (1) developing education programs or public health |
2 | | interventions relating to prescribing trends and |
3 | | controlled substance use; or |
4 | | (2) conducting analyses and publish reports on |
5 | | prescribing trends in their respective jurisdictions. |
6 | | At a minimum, the confidentiality agreement entered into |
7 | | with the Department shall: |
8 | | (i) prohibit analysis and reports produced under |
9 | | subparagraph (2) from including information that |
10 | | identifies, by name, license, or address, any |
11 | | practitioner, dispenser, ultimate user, or other person |
12 | | administering a controlled substance; and |
13 | | (ii) specify the appropriate technical and physical |
14 | | safeguards that the county or municipal health department |
15 | | must implement to ensure the privacy and security of data |
16 | | obtained from the system. The data from the system shall |
17 | | not be admissible as evidence, nor discoverable in any |
18 | | action of any kind in any court or before any tribunal, |
19 | | board, agency, or person. The disclosure of any such |
20 | | information or data, whether proper or improper, shall not |
21 | | waive or have any effect upon its confidentiality, |
22 | | non-discoverability, or non-admissibility. |
23 | | (g) The information described in subsection (f) may not be |
24 | | released until it has been reviewed by an employee of the |
25 | | Department who is licensed as a prescriber or a dispenser and |
26 | | until that employee has certified that further investigation |
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1 | | is warranted. Upon review and approval by a licensed |
2 | | prescriber or dispenser, or trained designee, the Prescription |
3 | | Monitoring Program may release information described in |
4 | | subsection (f). However, failure to comply with this |
5 | | subsection (g) does not invalidate the use of any evidence |
6 | | that is otherwise admissible in a proceeding described in |
7 | | subsection (h). |
8 | | (h) An investigator or a law enforcement officer receiving |
9 | | confidential information under subsection (c), (d), or (f) may |
10 | | disclose the information to a law enforcement officer or an |
11 | | attorney for the office of the Attorney General for use as |
12 | | evidence in the following: |
13 | | (1) A proceeding under any State or federal law that |
14 | | involves a controlled substance. |
15 | | (2) A criminal proceeding or a proceeding in juvenile |
16 | | court that involves a controlled substance. |
17 | | (i) The Department may compile statistical reports from |
18 | | the information described in subsection (a). The reports must |
19 | | not include information that identifies, by name, license or |
20 | | address, any practitioner, dispenser, ultimate user, or other |
21 | | person administering a controlled substance. |
22 | | (j) Based upon federal, initial and maintenance funding, a |
23 | | prescriber and dispenser inquiry system shall be developed to |
24 | | assist the health care community in its goal of effective |
25 | | clinical practice and to prevent patients from diverting or |
26 | | abusing medications. |
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1 | | (1) An inquirer shall have read-only access to a |
2 | | stand-alone database which shall contain records for the |
3 | | previous 12 months. |
4 | | (2) Dispensers may, upon positive and secure |
5 | | identification, make an inquiry on a patient or customer |
6 | | solely for a medical purpose as delineated within the |
7 | | federal HIPAA law. |
8 | | (3) The Department shall provide a one-to-one secure |
9 | | link and encrypted software necessary to establish the |
10 | | link between an inquirer and the Department. Technical |
11 | | assistance shall also be provided. |
12 | | (4) Written inquiries are acceptable but must include |
13 | | the fee and the requester's Drug Enforcement |
14 | | Administration license number and submitted upon the |
15 | | requester's business stationery. |
16 | | (5) As directed by the Prescription Monitoring Program |
17 | | Advisory Committee and the Clinical Director for the |
18 | | Prescription Monitoring Program, aggregate data that does |
19 | | not indicate any prescriber, practitioner, dispenser, or |
20 | | patient may be used for clinical studies. |
21 | | (6) Tracking analysis shall be established and used |
22 | | per administrative rule. |
23 | | (7) Nothing in this Act or Illinois law shall be |
24 | | construed to require a prescriber or dispenser to make use |
25 | | of this inquiry system. |
26 | | (8) If there is an adverse outcome because of a |
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1 | | prescriber or dispenser making an inquiry, which is |
2 | | initiated in good faith, the prescriber or dispenser shall |
3 | | be held harmless from any civil liability. |
4 | | (k) The Department shall establish, by rule, the process |
5 | | by which to evaluate possible erroneous association of |
6 | | prescriptions to any licensed prescriber or end user of the |
7 | | Illinois Prescription Information Library (PIL). |
8 | | (l) The Prescription Monitoring Program Advisory Committee |
9 | | is authorized to evaluate the need for and method of |
10 | | establishing a patient specific identifier. |
11 | | (m) Patients who identify prescriptions attributed to them |
12 | | that were not obtained by them shall be given access to their |
13 | | personal prescription history pursuant to the validation |
14 | | process as set forth by administrative rule. |
15 | | (n) The Prescription Monitoring Program is authorized to |
16 | | develop operational push reports to entities with compatible |
17 | | electronic medical records. The process shall be covered |
18 | | within administrative rule established by the Department. |
19 | | (o) Hospital emergency departments and freestanding |
20 | | healthcare facilities providing healthcare to walk-in patients |
21 | | may obtain, for the purpose of improving patient care, a |
22 | | unique identifier for each shift to utilize the PIL system. |
23 | | (p) The Prescription Monitoring Program shall |
24 | | automatically create a log-in to the inquiry system when a |
25 | | prescriber or dispenser obtains or renews his or her |
26 | | controlled substance license. The Department of Financial and |
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1 | | Professional Regulation must provide the Prescription |
2 | | Monitoring Program with electronic access to the license |
3 | | information of a prescriber or dispenser to facilitate the |
4 | | creation of this profile. The Prescription Monitoring Program |
5 | | shall send the prescriber or dispenser information regarding |
6 | | the inquiry system, including instructions on how to log into |
7 | | the system, instructions on how to use the system to promote |
8 | | effective clinical practice, and opportunities for continuing |
9 | | education for the prescribing of controlled substances. The |
10 | | Prescription Monitoring Program shall also send to all |
11 | | enrolled prescribers, dispensers, and designees information |
12 | | regarding the unsolicited reports produced pursuant to Section |
13 | | 314.5 of this Act. |
14 | | (q) A prescriber or dispenser may authorize a designee to |
15 | | consult the inquiry system established by the Department under |
16 | | this subsection on his or her behalf, provided that all the |
17 | | following conditions are met: |
18 | | (1) the designee so authorized is employed by the same |
19 | | hospital or health care system; is employed by the same |
20 | | professional practice; or is under contract with such |
21 | | practice, hospital, or health care system; |
22 | | (2) the prescriber or dispenser takes reasonable steps |
23 | | to ensure that such designee is sufficiently competent in |
24 | | the use of the inquiry system; |
25 | | (3) the prescriber or dispenser remains responsible |
26 | | for ensuring that access to the inquiry system by the |
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1 | | designee is limited to authorized purposes and occurs in a |
2 | | manner that protects the confidentiality of the |
3 | | information obtained from the inquiry system, and remains |
4 | | responsible for any breach of confidentiality; and |
5 | | (4) the ultimate decision as to whether or not to |
6 | | prescribe or dispense a controlled substance remains with |
7 | | the prescriber or dispenser. |
8 | | The Prescription Monitoring Program shall send to |
9 | | registered designees information regarding the inquiry system, |
10 | | including instructions on how to log onto the system. |
11 | | (r) The Prescription Monitoring Program shall maintain an |
12 | | Internet website in conjunction with its prescriber and |
13 | | dispenser inquiry system. This website shall include, at a |
14 | | minimum, the following information: |
15 | | (1) current clinical guidelines developed by health |
16 | | care professional organizations on the prescribing of |
17 | | opioids or other controlled substances as determined by |
18 | | the Advisory Committee; |
19 | | (2) accredited continuing education programs related |
20 | | to prescribing of controlled substances; |
21 | | (3) programs or information developed by health care |
22 | | professionals that may be used to assess patients or help |
23 | | ensure compliance with prescriptions; |
24 | | (4) updates from the Food and Drug Administration, the |
25 | | Centers for Disease Control and Prevention, and other |
26 | | public and private organizations which are relevant to |
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1 | | prescribing; |
2 | | (5) relevant medical studies related to prescribing; |
3 | | (6) other information regarding the prescription of |
4 | | controlled substances; and |
5 | | (7) information regarding prescription drug disposal |
6 | | events, including take-back programs or other disposal |
7 | | options or events. |
8 | | The content of the Internet website shall be periodically |
9 | | reviewed by the Prescription Monitoring Program Advisory |
10 | | Committee as set forth in Section 320 and updated in |
11 | | accordance with the recommendation of the advisory committee. |
12 | | (s) The Prescription Monitoring Program shall regularly |
13 | | send electronic updates to the registered users of the |
14 | | Program. The Prescription Monitoring Program Advisory |
15 | | Committee shall review any communications sent to registered |
16 | | users and also make recommendations for communications as set |
17 | | forth in Section 320. These updates shall include the |
18 | | following information: |
19 | | (1) opportunities for accredited continuing education |
20 | | programs related to prescribing of controlled substances; |
21 | | (2) current clinical guidelines developed by health |
22 | | care professional organizations on the prescribing of |
23 | | opioids or other drugs as determined by the Advisory |
24 | | Committee; |
25 | | (3) programs or information developed by health care |
26 | | professionals that may be used to assess patients or help |
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1 | | ensure compliance with prescriptions; |
2 | | (4) updates from the Food and Drug Administration, the |
3 | | Centers for Disease Control and Prevention, and other |
4 | | public and private organizations which are relevant to |
5 | | prescribing; |
6 | | (5) relevant medical studies related to prescribing; |
7 | | (6) other information regarding prescribing of |
8 | | controlled substances; |
9 | | (7) information regarding prescription drug disposal |
10 | | events, including take-back programs or other disposal |
11 | | options or events; and |
12 | | (8) reminders that the Prescription Monitoring Program |
13 | | is a useful clinical tool. |
14 | | (t) Notwithstanding any other provision of this Act, |
15 | | neither the Prescription Monitoring Program nor any other |
16 | | person shall disclose any information in violation of the |
17 | | restrictions and requirements of paragraph (3.5) of subsection |
18 | | (a) of Section 316 as implemented under Public Act 102-527. |
19 | | (Source: P.A. 102-751, eff. 1-1-23; 103-881, eff. 1-1-25.) |
20 | | Section 95. No acceleration or delay. Where this Act makes |
21 | | changes in a statute that is represented in this Act by text |
22 | | that is not yet or no longer in effect (for example, a Section |
23 | | represented by multiple versions), the use of that text does |
24 | | not accelerate or delay the taking effect of (i) the changes |
25 | | made by this Act or (ii) provisions derived from any other |