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.
TITLE OF BILL: An act to amend the public health law, in relation to establishing a prescription monitoring program
PURPOSE OR GENERAL IDEA OF BILL: To establish a new prescription monitoring program that requires medical professionals and pharmacists to report and track prescriptions of controlled substances.
SUMMARY OF SPECIFIC PROVISIONS: Section 1 amends Article 33 of the public health law to add a new title 5-A, creating the New Prescription Monitoring Program.
§3355 defines the bill as the "prescription monitoring act."
§3356 defines the advisory board.
§3357 establishes the prescription monitoring program.
§3358 describes composition of the advisory board to assist the New York State Department of Health in carrying out the duties of this act. The advisory board shall consist of a representative of the board of medicine, a representative of the board of pharmacy, a representative of the board of dental examiners, a representative of the state board of nursing, the attorney general or his or her designee, a representative of the Department Of Health appointed by the commissioner, a representative of the New York medical society, a representative of the New York state dental association, a representative of the New York state association of the chiefs of police, and a representative of retail pharmacy. Furthermore, the advisory board shall provide input and advice regarding the development and operation of the electronic monitoring system.
§3359 requires the reporting of prescription monitoring information and defines specific information the Department of Health shall decide how frequently this information shall be submitted by the dispenser. It also defines the granting of a waiver.
§3360 defines the access and confidentiality of the prescription monitoring program. It defines the review process, the release of information and who may access the information. It imposes immunity from civil liability to the New York State Department of Health.
§3361 defines the implementation of the education courses, who must take such courses and how the Department of Health, when appropriate, shall work with associations to provide intervention and treatment to individuals who have become addicted to substances monitored by the program.
§3362 describes the penalties for dispensers who fail to submit prescription drug monitoring information to the Department of Health, and penalties for persons who use, or knowingly disclose confidential information.
§3363 establishes the analysis and reporting of data.
§3364 sets forth rules and regulation to implement the provisions.
§3365 is the severability clause.
Section 2 provides that the Department of Health, in consultation with the prescription program monitoring board, establish regulations requiring pharmacists to access the program and to establish protocols to be followed after accessing such information.
Section 3 provides that within 180 days after the effective date of the legislation, the prescription monitoring advisory board make recommendations and submit a written report to the legislature concerning integrating prescribers into the electronic submission requirements of the prescription monitoring program, as well as any possible changes to the official New York state prescription form for controlled substances to include more information concerning a patient's controlled substance use.
Section 4 is the effective date; this act shall take effect on the ninetieth day after it shall have become law.
JUSTIFICATION: The abuse of prescription drugs has become a growing epidemic. More and more people are turning to oxycodone, which is used to relieve moderate to severe pain. Oxycodone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain. Unfortunately, it is being abused by certain individuals, instead of drugs such as heroin because they get the same "high." Recent reports state that the number of emergency room visits resulting from the abuse of prescription drugs has nearly doubled over the last five years. The Substance Abuse and Mental Health Services report that there were approximately 1.2 million visits to emergency rooms involving pharmaceutical drugs in 2009 compared with 627,000 in 2004. Further statistics report that in the Borough of Staten Island, over 110,000 prescriptions are written for oxycodone every year. According to the Borough's District Attorney, these statistics make Staten Island the second highest county in New York State to write oxycodone prescriptions.
The state department of health already has in place a limited prescription monitoring program (Article 33 of the Public Health Law and Part 80 of Title 10 regulations). This is a good first step but it is clear that it does not do enough to solve this horrific prescription drug abuse problem. This bill (and a companion bill) seeks to strengthen the current program. An obvious oversight in the current NYSDOH's monitoring program is that doctors and pharmacists are not required to access the data base before prescribing a controlled substance to their patients. In addition, only pharmacists and not doctors are required to . report. Nor are they required to report the written prescription. For these reasons, reporting and accessing the database by pharmacists and medical professionals clearly needs to be mandated. New York's laws and regulations in regard to sharing of this information clearly need
to be strengthened. Unfortunately, we have fallen behind those of other states.
This legislation will link the medical profession with the pharmacies to combat the abuse of controlled substance prescriptions. It also will enable all parties involved with an individual patient's healthcare decisions to have information necessary to make the right prescription drug choices.
Currently, 39 States have prescription drug monitoring laws of some sort.
This bill, if passed into law, would enable all of the parties involved in an individual patient's healthcare decisions to have information necessary to make the right prescription drug choices. It is also part of a two bill package to strengthen New York State's Prescription Monitoring Program.
PRIOR LEGISLATIVE HISTORY: New bill.
FISCAL IMPLICATIONS: None.
EFFECTIVE DATE: This act shall take effect on the ninetieth day after it shall have become law.
STATE OF NEW YORK ________________________________________________________________________ 2819 2011-2012 Regular Sessions IN SENATE February 2, 2011 ___________Introduced by Sen. LANZA -- read twice and ordered printed, and when printed to be committed 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: Section 1. Article 33 of the public health law is amended by adding a new title 5-A to read as follows: TITLE V-A PRESCRIPTION MONITORING PROGRAM SECTION 3355. SHORT TITLE. 3356. DEFINITIONS. 3357. ESTABLISHMENT OF A PRESCRIPTION MONITORING PROGRAM. 3358. ADVISORY BOARD. 3359. REPORTING OF PRESCRIPTION MONITORING INFORMATION. 3360. ACCESS TO THE PRESCRIPTION MONITORING INFORMATION; CONFI- DENTIALITY. 3361. EDUCATION AND TREATMENT. 3362. UNLAWFUL ACTS AND PENALTIES. 3363. EVALUATION, DATA ANALYSIS AND REPORTING. 3364. RULES AND REGULATIONS. 3365. SEVERABILITY. S 3355. SHORT TITLE. THIS ACT SHALL BE KNOWN AND MAY BE CITED AS THE "PRESCRIPTION MONITORING ACT". S 3356. DEFINITIONS. 1. "BOARD" MEANS THE ADVISORY BOARD ESTABLISHED UNDER SECTION THIRTY-THREE HUNDRED FIFTY-EIGHT OF THIS TITLE. 2. "DISPENSER" MEANS A PERSON AUTHORIZED IN THIS STATE TO DISTRIBUTE TO THE ULTIMATE USER A SUBSTANCE MONITORED BY THE PRESCRIPTION MONITOR- ING PROGRAM, BUT DOES NOT INCLUDE: (A) A LICENSED HOSPITAL PHARMACY THAT DISTRIBUTES SUCH SUBSTANCES FOR THE PURPOSES OF INPATIENT HOSPITAL CARE OR THE DISPENSING OFEXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD08321-02-1 S. 2819 2
PRESCRIPTIONS FOR CONTROLLED SUBSTANCES AT THE TIME OF DISCHARGE FROM SUCH A FACILITY; (B) A LICENSED NURSE OR MEDICATION AIDE WHO ADMINISTERS SUCH A SUBSTANCE AT THE DIRECTION OF A LICENSED PHYSICIAN; OR (C) A WHOLESALE DISTRIBUTOR OF A SUBSTANCE MONITORED BY THE PRESCRIPTION MONITORING PROGRAM. 3. "PRESCRIBER" MEANS A LICENSED HEALTH CARE PROFESSIONAL WITH PRES- CRIPTIVE AUTHORITY. 4. "PRESCRIPTION MONITORING INFORMATION" MEANS INFORMATION SUBMITTED TO AND MAINTAINED BY THE PRESCRIPTION MONITORING PROGRAM. 5. "PRESCRIPTION MONITORING PROGRAM" MEANS A PROGRAM ESTABLISHED UNDER SECTION THIRTY-THREE HUNDRED FIFTY-SEVEN OF THIS TITLE. S 3357. ESTABLISHMENT OF A PRESCRIPTION MONITORING PROGRAM. 1. THE DEPARTMENT SHALL ESTABLISH AND MAINTAIN, WITH THE CONSULTATION OF THE BOARD, AN ELECTRONIC SYSTEM FOR MONITORING THE FOLLOWING SUBSTANCES DISPENSED IN THE STATE: FEDERALLY CONTROLLED SUBSTANCES, ADDITIONAL STATE SPECIFIED CONTROLLED SUBSTANCES, AND DRUGS OF CONCERN DOCUMENTED TO DEMONSTRATE A POTENTIAL FOR ABUSE, PARTICULARLY THOSE IDENTIFIED BY LAW ENFORCEMENT AND ADDICTION TREATMENT PROFESSIONALS. 2. THE DEPARTMENT MAY CONTRACT WITH A VENDOR TO ESTABLISH AND MAINTAIN THE ELECTRONIC MONITORING SYSTEM PURSUANT TO GUIDELINES WHICH THE DEPARTMENT SHALL PROMULGATE. S 3358. ADVISORY BOARD. 1. THERE IS HEREBY ESTABLISHED AN ADVISORY BOARD TO ASSIST THE DEPARTMENT IN CARRYING OUT THE DUTIES OF THIS ARTI- CLE. THE ADVISORY BOARD SHALL CONSIST OF THE FOLLOWING MEMBERS: (A) A REPRESENTATIVE OF THE STATE BOARD OF MEDICINE, APPOINTED BY THE BOARD. (B) A REPRESENTATIVE OF THE STATE BOARD OF PHARMACY, APPOINTED BY THE BOARD. (C) A REPRESENTATIVE OF THE STATE BOARD OF DENTAL EXAMINERS, APPOINTED BY THE BOARD. (D) A REPRESENTATIVE OF THE STATE BOARD OF NURSING, APPOINTED BY THE BOARD. (E) THE ATTORNEY GENERAL OR HIS OR HER DESIGNEE. (F) A REPRESENTATIVE OF THE DEPARTMENT, APPOINTED BY THE COMMISSIONER. (G) A REPRESENTATIVE OF THE NEW YORK STATE MEDICAL SOCIETY, APPOINTED BY THE SOCIETY. (H) A REPRESENTATIVE OF THE NEW YORK STATE DENTAL ASSOCIATION, APPOINTED BY THE ASSOCIATION. (I) A REPRESENTATIVE OF THE NEW YORK STATE ASSOCIATION OF CHIEFS OF POLICE, APPOINTED BY THE ASSOCIATION. (J) A REPRESENTATIVE OF RETAIL PHARMACY, APPOINTED BY THE NEW YORK STATE PHARMACISTS ASSOCIATION. 2. THE DEPARTMENT SHALL SEEK AND THE BOARD SHALL PROVIDE INPUT AND ADVICE REGARDING THE DEVELOPMENT AND OPERATION OF THE ELECTRONIC MONI- TORING SYSTEM, INCLUDING BUT NOT LIMITED TO: (A) WHICH STATE CONTROLLED SUBSTANCES SHOULD BE MONITORED; (B) WHICH DRUGS OF CONCERN DEMONSTRATE A POTENTIAL FOR ABUSE AND SHOULD BE MONITORED; (C) DESIGN AND IMPLEMENTATION OF EDUCATIONAL COURSES IDENTIFIED IN SECTION THIRTY-THREE HUNDRED SIXTY-ONE OF THIS TITLE; (D) PROPER ANALYSIS AND INTERPRETATION OF PRESCRIPTION MONITORING INFORMATION; (E) DESIGN AND IMPLEMENTATION OF AN EVALUATION COMPONENT; AND (F) POTENTIAL NOMINEES TO THE BOARD.S. 2819 3
S 3359. REPORTING OF PRESCRIPTION MONITORING INFORMATION. 1. EACH DISPENSER SHALL SUBMIT TO THE DEPARTMENT, BY ELECTRONIC MEANS, OR OTHER FORMAT SPECIFIED IN A WAIVER GRANTED BY THE DEPARTMENT, INFORMATION SPECIFIED BY THE DEPARTMENT, INCLUDING: (A) A PATIENT IDENTIFIER, (B) THE DRUG PRESCRIBED OR DISPENSED, (C) THE DATE OF THE PRESCRIPTION OR DISPENSING, (D) THE QUANTITY PRESCRIBED OR DISPENSED, (E) THE PRESCRIBER, AND (F) THE DISPENSER. 2. EACH DISPENSER SHALL SUBMIT THE REQUIRED INFORMATION AS FREQUENTLY AS SPECIFIED BY THE DEPARTMENT. 3. THE DEPARTMENT MAY GRANT A WAIVER OF ELECTRONIC SUBMISSION TO ANY DISPENSER FOR GOOD CAUSE, INCLUDING FINANCIAL HARDSHIP, AS DETERMINED BY THE DEPARTMENT. THE WAIVER SHALL STATE THE FORMAT AND FREQUENCY WITH WHICH THE DISPENSER SHALL SUBMIT THE REQUIRED INFORMATION. S 3360. ACCESS TO THE PRESCRIPTION MONITORING INFORMATION; CONFIDEN- TIALITY. 1. EXCEPT AS INDICATED IN SUBDIVISIONS TWO, THREE, AND FOUR OF THIS SECTION, PRESCRIPTION MONITORING INFORMATION SUBMITTED TO THE DEPARTMENT SHALL BE CONFIDENTIAL AND NOT SUBJECT TO PUBLIC OR OPEN RECORDS LAWS. 2. THE DEPARTMENT SHALL REVIEW THE PRESCRIPTION MONITORING INFORMA- TION. IF THERE IS REASONABLE CAUSE TO BELIEVE A VIOLATION OF LAW OR BREACH OF OCCUPATIONAL STANDARDS MAY HAVE OCCURRED, THE DEPARTMENT SHALL NOTIFY THE APPROPRIATE LAW ENFORCEMENT AND OCCUPATIONAL LICENSING, CERTIFICATION OR REGULATORY AGENCY OR ENTITY, AND PROVIDE PRESCRIPTION MONITORING INFORMATION REQUIRED FOR AN INVESTIGATION. 3. THE DEPARTMENT MAY PROVIDE PRESCRIPTION MONITORING INFORMATION FOR PUBLIC RESEARCH, POLICY OR EDUCATION PURPOSES, TO THE EXTENT ALL INFOR- MATION REASONABLY LIKELY TO REVEAL THE PATIENT OR OTHER PERSON WHO IS THE SUBJECT OF THE INFORMATION HAS BEEN REMOVED. 4. THE FOLLOWING PERSONS, AFTER SUCCESSFUL COMPLETION OF THE EDUCA- TIONAL COURSES IDENTIFIED IN SUBDIVISION ONE OF SECTION THIRTY-THREE HUNDRED SIXTY-ONE OF THIS TITLE, MAY ACCESS THE PRESCRIPTION MONITORING INFORMATION IN THE SAME OR SIMILAR MANNER, AND FOR THE SAME OR SIMILAR PURPOSES, AS THOSE PERSONS ARE AUTHORIZED TO ACCESS SIMILAR CONFIDENTIAL INFORMATION UNDER FEDERAL AND STATE LAW AND REGULATION. (A) A CRIMINAL JUSTICE AGENCY WHICH ENFORCES THE LAWS OF THIS STATE OR THE UNITED STATES RELATING TO CONTROLLED SUBSTANCES AND WHICH HAS INITI- ATED AN ACTIVE INVESTIGATION INVOLVING A SPECIFIC VIOLATION OF LAW. (B) A PRACTITIONER, AS DEFINED IN SECTION THIRTY-THREE HUNDRED TWO OF THIS ARTICLE, OR AN EMPLOYEE OF THE PRACTITIONER WHO IS ACTING ON BEHALF OF AND AT THE DIRECTION OF THE PRACTITIONER, WHO REQUESTS SUCH INFORMA- TION AND CERTIFIES THAT THE INFORMATION IS NECESSARY TO PROVIDE MEDICAL TREATMENT TO A CURRENT PATIENT. (C) A PHARMACIST, AS DEFINED IN SECTION THIRTY-THREE HUNDRED TWO OF THIS ARTICLE, OR A PHARMACY INTERN OR PHARMACY TECHNICIAN WHO IS ACTING ON BEHALF OF AND AT THE DIRECTION OF THE PHARMACIST, WHO REQUESTS SUCH INFORMATION AND CERTIFIES THAT THE REQUESTED INFORMATION WILL BE USED TO DISPENSE CONTROLLED SUBSTANCES TO A CURRENT PATIENT. (D) A PATIENT WHO IS IDENTIFIED IN THE RECORD UPON A WRITTEN REQUEST FOR THE PURPOSE OF VERIFYING THAT INFORMATION. 5. A PERSON WHO HAS KNOWLEDGE BY VIRTUE OF HIS OR HER OFFICE OF THE CONTROLLED SUBSTANCES PRESCRIBED TO OR OBTAINED BY A PARTICULAR PERSON SHALL DISCLOSE SUCH KNOWLEDGE TO A PHARMACY TO INFORM THE PHARMACY THAT SUCH PERSON WHO PRESENTS OR HAS PRESENTED A PRESCRIPTION FOR ONE OR MORES. 2819 4
CONTROLLED SUBSTANCES AT THE PHARMACY MAY HAVE ALSO OBTAINED ONE OR MORE CONTROLLED SUBSTANCES AT ANOTHER PHARMACY WHERE THE CIRCUMSTANCES INDI- CATE A POSSIBILITY OF DRUG ABUSE OR DIVERSION, POTENTIAL HARM TO THE PERSON, OR SIMILAR GROUNDS UNDER REGULATIONS OF THE COMMISSIONER. 6. THE DEPARTMENT SHALL BE IMMUNE FROM CIVIL LIABILITY ARISING FROM INACCURACY OF ANY OF THE INFORMATION SUBMITTED TO THE DEPARTMENT PURSU- ANT TO THIS TITLE. S 3361. EDUCATION AND TREATMENT. 1. THE DEPARTMENT OF HEALTH SHALL, IN CONSULTATION WITH THE BOARD, IMPLEMENT THE FOLLOWING EDUCATION COURSES: (A) AN ORIENTATION COURSE DURING THE IMPLEMENTATION PHASE OF THE PRESCRIPTION MONITORING PROGRAM. (B) A COURSE FOR PERSONS WHO ARE AUTHORIZED TO ACCESS THE PRESCRIPTION MONITORING INFORMATION BUT WHO DID NOT PARTICIPATE IN THE ORIENTATION COURSE. (C) A COURSE FOR PERSONS WHO ARE AUTHORIZED TO ACCESS THE PRESCRIPTION MONITORING INFORMATION BUT WHO HAVE VIOLATED LAWS OR BREACHED OCCUPA- TIONAL STANDARDS INVOLVING DISPENSING, PRESCRIBING AND USE OF SUBSTANCES MONITORED BY THE PRESCRIPTION MONITORING PROGRAM. (D) A CONTINUING EDUCATION COURSE FOR HEALTH CARE PROFESSIONALS DEVEL- OPED BY THE AMERICAN SOCIETY OF ADDICTION MEDICINE AND THE STATE MEDICAL SOCIETY ON PRESCRIBING PRACTICES, PHARMACOLOGY AND IDENTIFICATION, TREATMENT AND REFERRAL OF PATIENTS ADDICTED TO OR ABUSING SUBSTANCES MONITORED BY THE PRESCRIPTION MONITORING PROGRAM. WHEN APPROPRIATE, THE DEPARTMENT, IN CONSULTATION WITH THE BOARD, SHALL DEVELOP THE CONTENT OF THE EDUCATION COURSES DESCRIBED IN PARA- GRAPHS (A), (B) AND (C) OF THIS SUBDIVISION. 2. THE DEPARTMENT, IN CONSULTATION WITH THE BOARD, SHALL STRONGLY RECOMMEND THE APPLICATION OF A COURSE TO INFORM THE PUBLIC ABOUT USE, DIVERSION AND ABUSE OF, AND ADDICTION TO, SUBSTANCES MONITORED BY THE PRESCRIPTION MONITORING PROGRAM. 3. THE DEPARTMENT, IN CONSULTATION WITH THE BOARD, SHALL, WHEN APPRO- PRIATE: (A) WORK WITH ASSOCIATIONS FOR IMPAIRED PROFESSIONALS TO ENSURE INTER- VENTION, TREATMENT AND ONGOING MONITORING AND FOLLOW-UP; AND (B) ENSURE THAT INDIVIDUAL PATIENTS WHO ARE IDENTIFIED AND WHO HAVE BECOME ADDICTED TO SUBSTANCES MONITORED BY THE PRESCRIPTION MONITORING PROGRAM RECEIVE ADDICTION TREATMENT. S 3362. UNLAWFUL ACTS AND PENALTIES. 1. A DISPENSER WHO KNOWINGLY FAILS TO SUBMIT PRESCRIPTION MONITORING INFORMATION TO THE DEPARTMENT AS REQUIRED BY THIS TITLE SHALL BE SUBJECT TO A FINE OF ONE THOUSAND FIVE HUNDRED DOLLARS. 2. A PERSON AUTHORIZED TO HAVE PRESCRIPTION MONITORING INFORMATION PURSUANT TO THIS TITLE WHO KNOWINGLY DISCLOSES SUCH INFORMATION IN VIOLATION OF THIS TITLE SHALL BE SUBJECT TO A FINE OF ONE THOUSAND DOLLARS. 3. A PERSON AUTHORIZED TO HAVE PRESCRIPTION MONITORING INFORMATION PURSUANT TO THIS TITLE WHO USES SUCH INFORMATION IN A MANNER OR FOR A PURPOSE IN VIOLATION OF THIS TITLE SHALL BE SUBJECT TO A FINE OF FIVE HUNDRED DOLLARS. S 3363. EVALUATION, DATA ANALYSIS AND REPORTING. 1. THE DEPARTMENT SHALL, IN CONSULTATION WITH THE BOARD, DESIGN AND IMPLEMENT AN EVALU- ATION COMPONENT TO IDENTIFY COST-BENEFITS OF THE PRESCRIPTION MONITORING PROGRAM, AND OTHER INFORMATION RELEVANT TO POLICY, RESEARCH AND EDUCA- TION INVOLVING SUBSTANCES MONITORED BY THE PRESCRIPTION MONITORING PROGRAM.S. 2819 5
2. THE DEPARTMENT SHALL REPORT TO THE LEGISLATURE ON A PERIODIC BASIS, NO LESS THAN ANNUALLY, ABOUT THE COST-BENEFITS AND OTHER INFORMATION NOTED IN SUBDIVISION ONE OF THIS SECTION. S 3364. RULES AND REGULATIONS. THE DEPARTMENT SHALL PROMULGATE RULES AND REGULATIONS NECESSARY TO IMPLEMENT THE PROVISIONS OF THIS TITLE. S 3365. SEVERABILITY. IF ANY PROVISION OF THIS TITLE OR APPLICATION THEREOF TO ANY PERSON OR CIRCUMSTANCE IS HELD INVALID, THE INVALIDITY SHALL NOT AFFECT OTHER PROVISIONS OR APPLICATIONS OF THE TITLE WHICH CAN BE GIVEN EFFECT WITHOUT THE INVALID PROVISIONS OR APPLICATIONS, AND TO THIS END THE PROVISIONS OF THIS TITLE ARE SEVERABLE. S 2. The department of health shall, within 180 days after the effec- tive date of this act, and after consultation with the Prescription Monitoring Program Advisory Board, establish regulations requiring phar- macists to access the prescription monitoring program before filling a prescription for a controlled substance. The department of health shall also establish protocols to be followed by pharmacists after accessing such information. S 3. The Prescription Monitoring Program Advisory Board shall, within 180 days after the effective date of this act, make recommendations and submit a written report to the legislature concerning integrating pres- cribers into the electronic submission requirements of the prescription monitoring program as well as any possible changes to the official New York state prescription form for controlled substances to include more information concerning a patient's controlled substance use. S 4. This act shall take effect on the ninetieth day after it shall have become a law.