Establishes a prescription monitoring program; requires the department of health to create an electronic prescription monitoring program and requires pharmacists to submit certain information to such program every time a controlled substance is prescribed or dispensed.
STATE OF NEW YORK
________________________________________________________________________
3807
2011-2012 Regular Sessions
IN ASSEMBLY
January 27, 2011
___________
Introduced by M. of A. CUSICK -- read once and referred to the Committee
on Health
AN ACT to amend the public health law, in relation to establishing a
prescription monitoring program
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Article 33 of the public health law is amended by adding a
2 new title 5-A to read as follows:
3 TITLE V-A
4 PRESCRIPTION MONITORING PROGRAM
5 Section 3355. Short title.
6 3356. Definitions.
7 3357. Establishment of a prescription monitoring program.
8 3358. Advisory board.
9 3359. Reporting of prescription monitoring information.
10 3360. Access to the prescription monitoring information; confi-
11 dentiality.
12 3361. Education and treatment.
13 3362. Unlawful acts and penalties.
14 3363. Evaluation, data analysis and reporting.
15 3364. Rules and regulations.
16 3365. Severability.
17 § 3355. Short title. This act shall be known and may be cited as the
18 "prescription monitoring act".
19 § 3356. Definitions. 1. "Board" means the advisory board established
20 under section thirty-three hundred fifty-eight of this title.
21 2. "Dispenser" means a person authorized in this state to distribute
22 to the ultimate user a substance monitored by the prescription monitor-
23 ing program, but does not include:
24 (a) a licensed hospital pharmacy that distributes such substances for
25 the purposes of inpatient hospital care or the dispensing of
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD08321-02-1
A. 3807 2
1 prescriptions for controlled substances at the time of discharge from
2 such a facility;
3 (b) a licensed nurse or medication aide who administers such a
4 substance at the direction of a licensed physician; or
5 (c) a wholesale distributor of a substance monitored by the
6 prescription monitoring program.
7 3. "Prescriber" means a licensed health care professional with pres-
8 criptive authority.
9 4. "Prescription monitoring information" means information submitted
10 to and maintained by the prescription monitoring program.
11 5. "Prescription monitoring program" means a program established under
12 section thirty-three hundred fifty-seven of this title.
13 § 3357. Establishment of a prescription monitoring program. 1. The
14 department shall establish and maintain, with the consultation of the
15 board, an electronic system for monitoring the following substances
16 dispensed in the state: federally controlled substances, additional
17 state specified controlled substances, and drugs of concern documented
18 to demonstrate a potential for abuse, particularly those identified by
19 law enforcement and addiction treatment professionals.
20 2. The department may contract with a vendor to establish and maintain
21 the electronic monitoring system pursuant to guidelines which the
22 department shall promulgate.
23 § 3358. Advisory board. 1. There is hereby established an advisory
24 board to assist the department in carrying out the duties of this arti-
25 cle. The advisory board shall consist of the following members:
26 (a) A representative of the state board of medicine, appointed by the
27 board.
28 (b) A representative of the state board of pharmacy, appointed by the
29 board.
30 (c) A representative of the state board of dental examiners, appointed
31 by the board.
32 (d) A representative of the state board of nursing, appointed by the
33 board.
34 (e) The attorney general or his or her designee.
35 (f) A representative of the department, appointed by the commissioner.
36 (g) A representative of the New York state medical society, appointed
37 by the society.
38 (h) A representative of the New York state dental association,
39 appointed by the association.
40 (i) A representative of the New York state association of chiefs of
41 police, appointed by the association.
42 (j) A representative of retail pharmacy, appointed by the New York
43 state pharmacists association.
44 2. The department shall seek and the board shall provide input and
45 advice regarding the development and operation of the electronic moni-
46 toring system, including but not limited to:
47 (a) which state controlled substances should be monitored;
48 (b) which drugs of concern demonstrate a potential for abuse and
49 should be monitored;
50 (c) design and implementation of educational courses identified in
51 section thirty-three hundred sixty-one of this title;
52 (d) proper analysis and interpretation of prescription monitoring
53 information;
54 (e) design and implementation of an evaluation component; and
55 (f) potential nominees to the board.
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1 § 3359. Reporting of prescription monitoring information. 1. Each
2 dispenser shall submit to the department, by electronic means, or other
3 format specified in a waiver granted by the department, information
4 specified by the department, including:
5 (a) A patient identifier,
6 (b) The drug prescribed or dispensed,
7 (c) The date of the prescription or dispensing,
8 (d) The quantity prescribed or dispensed,
9 (e) The prescriber, and
10 (f) The dispenser.
11 2. Each dispenser shall submit the required information as frequently
12 as specified by the department.
13 3. The department may grant a waiver of electronic submission to any
14 dispenser for good cause, including financial hardship, as determined by
15 the department. The waiver shall state the format and frequency with
16 which the dispenser shall submit the required information.
17 § 3360. Access to the prescription monitoring information; confiden-
18 tiality. 1. Except as indicated in subdivisions two, three, and four of
19 this section, prescription monitoring information submitted to the
20 department shall be confidential and not subject to public or open
21 records laws.
22 2. The department shall review the prescription monitoring informa-
23 tion. If there is reasonable cause to believe a violation of law or
24 breach of occupational standards may have occurred, the department shall
25 notify the appropriate law enforcement and occupational licensing,
26 certification or regulatory agency or entity, and provide prescription
27 monitoring information required for an investigation.
28 3. The department may provide prescription monitoring information for
29 public research, policy or education purposes, to the extent all infor-
30 mation reasonably likely to reveal the patient or other person who is
31 the subject of the information has been removed.
32 4. The following persons, after successful completion of the educa-
33 tional courses identified in subdivision one of section thirty-three
34 hundred sixty-one of this title, may access the prescription monitoring
35 information in the same or similar manner, and for the same or similar
36 purposes, as those persons are authorized to access similar confidential
37 information under federal and state law and regulation.
38 (a) A criminal justice agency which enforces the laws of this state or
39 the United States relating to controlled substances and which has initi-
40 ated an active investigation involving a specific violation of law.
41 (b) A practitioner, as defined in section thirty-three hundred two of
42 this article, or an employee of the practitioner who is acting on behalf
43 of and at the direction of the practitioner, who requests such informa-
44 tion and certifies that the information is necessary to provide medical
45 treatment to a current patient.
46 (c) A pharmacist, as defined in section thirty-three hundred two of
47 this article, or a pharmacy intern or pharmacy technician who is acting
48 on behalf of and at the direction of the pharmacist, who requests such
49 information and certifies that the requested information will be used to
50 dispense controlled substances to a current patient.
51 (d) A patient who is identified in the record upon a written request
52 for the purpose of verifying that information.
53 5. A person who has knowledge by virtue of his or her office of the
54 controlled substances prescribed to or obtained by a particular person
55 shall disclose such knowledge to a pharmacy to inform the pharmacy that
56 such person who presents or has presented a prescription for one or more
A. 3807 4
1 controlled substances at the pharmacy may have also obtained one or more
2 controlled substances at another pharmacy where the circumstances indi-
3 cate a possibility of drug abuse or diversion, potential harm to the
4 person, or similar grounds under regulations of the commissioner.
5 6. The department shall be immune from civil liability arising from
6 inaccuracy of any of the information submitted to the department pursu-
7 ant to this title.
8 § 3361. Education and treatment. 1. The department of health shall, in
9 consultation with the board, implement the following education courses:
10 (a) An orientation course during the implementation phase of the
11 prescription monitoring program.
12 (b) A course for persons who are authorized to access the prescription
13 monitoring information but who did not participate in the orientation
14 course.
15 (c) A course for persons who are authorized to access the prescription
16 monitoring information but who have violated laws or breached occupa-
17 tional standards involving dispensing, prescribing and use of substances
18 monitored by the prescription monitoring program.
19 (d) A continuing education course for health care professionals devel-
20 oped by the American Society of Addiction Medicine and the state medical
21 society on prescribing practices, pharmacology and identification,
22 treatment and referral of patients addicted to or abusing substances
23 monitored by the prescription monitoring program.
24 When appropriate, the department, in consultation with the board,
25 shall develop the content of the education courses described in para-
26 graphs (a), (b) and (c) of this subdivision.
27 2. The department, in consultation with the board, shall strongly
28 recommend the application of a course to inform the public about use,
29 diversion and abuse of, and addiction to, substances monitored by the
30 prescription monitoring program.
31 3. The department, in consultation with the board, shall, when appro-
32 priate:
33 (a) work with associations for impaired professionals to ensure inter-
34 vention, treatment and ongoing monitoring and follow-up; and
35 (b) ensure that individual patients who are identified and who have
36 become addicted to substances monitored by the prescription monitoring
37 program receive addiction treatment.
38 § 3362. Unlawful acts and penalties. 1. A dispenser who knowingly
39 fails to submit prescription monitoring information to the department as
40 required by this title shall be subject to a fine of one thousand five
41 hundred dollars.
42 2. A person authorized to have prescription monitoring information
43 pursuant to this title who knowingly discloses such information in
44 violation of this title shall be subject to a fine of one thousand
45 dollars.
46 3. A person authorized to have prescription monitoring information
47 pursuant to this title who uses such information in a manner or for a
48 purpose in violation of this title shall be subject to a fine of five
49 hundred dollars.
50 § 3363. Evaluation, data analysis and reporting. 1. The department
51 shall, in consultation with the board, design and implement an evalu-
52 ation component to identify cost-benefits of the prescription monitoring
53 program, and other information relevant to policy, research and educa-
54 tion involving substances monitored by the prescription monitoring
55 program.
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1 2. The department shall report to the legislature on a periodic basis,
2 no less than annually, about the cost-benefits and other information
3 noted in subdivision one of this section.
4 § 3364. Rules and regulations. The department shall promulgate rules
5 and regulations necessary to implement the provisions of this title.
6 § 3365. Severability. If any provision of this title or application
7 thereof to any person or circumstance is held invalid, the invalidity
8 shall not affect other provisions or applications of the title which can
9 be given effect without the invalid provisions or applications, and to
10 this end the provisions of this title are severable.
11 § 2. The department of health shall, within 180 days after the effec-
12 tive date of this act, and after consultation with the Prescription
13 Monitoring Program Advisory Board, establish regulations requiring phar-
14 macists to access the prescription monitoring program before filling a
15 prescription for a controlled substance. The department of health shall
16 also establish protocols to be followed by pharmacists after accessing
17 such information.
18 § 3. The Prescription Monitoring Program Advisory Board shall, within
19 180 days after the effective date of this act, make recommendations and
20 submit a written report to the legislature concerning integrating pres-
21 cribers into the electronic submission requirements of the prescription
22 monitoring program as well as any possible changes to the official New
23 York state prescription form for controlled substances to include more
24 information concerning a patient's controlled substance use.
25 § 4. This act shall take effect on the ninetieth day after it shall
26 have become a law.
