Analysis Prepared by the Department of Safety and Professional Services
Statutes interpreted
Statutory authority
Explanation of agency authority
In s.
450.19 (2), Stats., as amended by
2009 Act 362, the legislature directs the Pharmacy Examining Board (Board) to establish by rule a prescription drug monitoring program (PDMP). In s.
961.31, Stats., the legislature authorizes the Board to promulgate rules relating to the dispensing of controlled substances. Finally, in ss.
15.08 (5) (b), and
227.11 (2) (a), Stats., the legislature confers to the Board the powers to promulgate rules for the guidance of the profession and to interpret the provisions of statutes it enforces.
Related statute or rule
Plain language analysis
The proposed rule creates a prescription drug monitoring program (PDMP) to collect and maintain data regarding the prescribing and dispensing of monitored prescription drugs. The monitored prescription drugs are federally controlled substances in Schedules II-V, state controlled substances in Schedules II-V, as amended by the Controlled Substances Board, and Tramadol, a drug identified by the Board as having a substantial potential for abuse. A controlled substance that can be legally dispensed without a prescription order is not a monitored prescription drug under the proposed rule.
In general, the proposed rule requires dispensers to compile and submit to the Board data about each time they dispense a monitored prescription drug within 7 days. The proposed rule also requires dispensers to submit reports to the Board for each 7-day period during which he or she does not dispense a monitored prescription drug. For each dispensing of any of a monitored prescription drug, dispensers must compile and submit the following data to the Board:
- dispenser's full name;
- dispenser's NPI number or DEA registration number;
- date dispensed;
- prescription number;
- name and strength of the prescription drug;
- NDC number;
- quantity dispensed;
- estimated number of days of drug therapy;
- practitioner's full name;
- practitioner's NPI number or DEA registration number, if applicable;
- date prescribed;
- quantity prescribed;
- patient's full name;
- patient's address, including street address, city, state and ZIP code;
- patient's date of birth; and
- patient's gender.
Under the proposed rule, the Board may waive the 7-day reporting requirements for dispensers who only dispense monitored prescription drugs to non-human animal patients. Instead, the dispensers would be required to submit the required data or report indicating that they have not dispensed a monitored prescription drug every 90 days.
The proposed rule requires dispensers to submit the data to the Board electronically, in the standard established by the American Society for Automation in Pharmacy's Implementation Guide for Prescription Monitoring Programs.
Under the proposed rule, the Board may grant waivers to dispensers who are not able to comply with the 7-day reporting or the electronic data submission requirements. Therefore, dispensers who are not able to comply with one or both of the reporting or submission requirements may submit to the Board an application for a waiver.
The proposed rule requires the Board to develop and maintain a database to store all of the data submitted to it as part of the PDMP. Practitioners and dispensers will be able create accounts with the Board to access the database and view information that may be helpful in determining whether a patient is using any of the specific prescription drugs illicitly. Further, under the proposed rule, other entities, such as law enforcement authorities, patients and staff of the Department of Safety and Professional Services, may obtain data from the Board as permitted under s.
146.82, Stats.
The proposed rule states that the data compiled and stored by the Board under the proposed rules is confidential and not subject to inspection or copying under the state's open records laws.
Under the proposed rule, the Board may exchange data obtained through the PDMP with relevant agencies and prescription monitoring programs in other states.
Summary of, and comparison with, existing or proposed federal legislation
There is no existing or proposed federal regulation.
Comparison with rules in adjacent states
Illinois: The statutes and administrative rules governing the Illinois Prescription Monitoring Program require dispensers to submit to a database similar information regarding the prescribing and dispensing of controlled substances (Schedules II-V) within seven days of the dispensing. See 720 Illinois Compiled Statutes 570/316-21 and Illinois Administrative Code Title 77, Chapter X, Subchapter e, Part 2080.
Iowa: The statutes and administrative rules governing the Iowa Prescription Monitoring Program require dispensers to submit to a database similar information regarding the prescribing and dispensing of controlled substances (Schedules II-IV) two times per month.
See Iowa Code §
124.551-58 and Iowa Administrative Code Title 657, Chapter
37.
Michigan: The statutes and administrative rules governing the Michigan Automated Prescription System require dispensers to submit to a database similar information regarding the prescribing and dispensing of controlled substances (Schedules II-V) two times per month.
See Michigan Public Health Code §
333.7333a and Michigan Administrative Code R. 338.471.
Minnesota: The statutes governing the Minnesota Prescription Monitoring Program require dispensers to submit to a database similar information regarding the prescribing and dispensing of controlled substances (Schedules II-IV) on a daily basis. See Minnesota Statute 152.126.
Summary of factual data and analytical methodologies
The Board created a Work Group to develop the proposed rule. The Work Group analyzed information from national non-profit organizations that compiled information about other states' prescription monitoring programs. Further, the organizations provided analysis regarding the effectiveness of differing prescription drug monitoring models and processes.
The Board has also solicited feedback from approximately forty stakeholders that represent practitioners, pharmacists, pharmacies, public health agencies and law enforcement agencies. Stakeholders have been updated throughout the development of the draft rules and have provided comments on the proposed rule. The Board will consult with the stakeholders as implementation of the PDMP continues.
Further, there are currently forty operational state prescription monitoring programs in the United States, including programs in all four states neighboring Wisconsin. The Work Group solicited and compiled information from states' operational prescription monitoring programs regarding best practices and techniques to minimize the burden on practitioners and dispensers. Importantly, the Work Group used the information to ensure the compatibility of the PDMP with prescription monitoring programs in other states and better situate itself for future federal grant funding as required by
2009 Act 362. The Work Group also identified criteria required to apply for other grants in an effort to maximize the possibility of obtaining future federal grant funding for the PDMP.
Finally, the Work Group relied on the requirements and guidelines of the Harold Rogers Grant that the department received to implement the PDMP. The federal grant requirements provide relevant information because they are based on best practices of operational PDMP and the previous experiences of grantees implementing prescription monitoring programs.
Analysis and supporting documents used to determine effect on small business or in preparation of Economic Impact Analysis
To prepare the Economic Impact Analysis and regulatory flexibility reports for the proposed rule, the department has actively solicited comments from the public and stakeholders representing pharmacies; pharmacists; health care practitioners, including physicians, dentists and veterinarians; hospitals; clinics and law enforcement officials since November 2011. Further, the department posted notice to solicit comments on the economic impact of the proposed rule on its website for more than 30-days, from December 16, 2011 to January 19, 2012. During that period, the department held an informal roundtable with stakeholders and members of the public who expressed interest on January 15, 2012 to solicit feedback.
During the solicitation period for comments regarding the economic impact of the proposed rule, the department received four comments that referred to the economic impact or funding of the PDMP. The comments are attached to the Economic Impact Analysis. Of the four comments, two provide specific estimates regarding the economic impact of the proposed rule on veterinarians in Wisconsin and two present general concerns regarding the ongoing funding of the PDMP beyond the federal grant.
For a complete analysis of the received comments, see the Fiscal Estimate, Economic Impact Analysis and Initial Regulatory Flexibility Analysis.
Anticipated costs incurred by the private sector
As described in the Economic Impact Analysis and Initial Regulatory Flexibility Analysis, the department anticipates that specific segments of the private sector may incur moderate costs to comply with the requirements of the proposed rule. However, while the health care sector may incur moderate costs to comply with the requirements of the proposed rule, the department does not find that the proposed rule would adversely affect in any material way the economy, any sector of the economy, productivity, jobs or the overall economic competitiveness of this state. Similarly, the department does not find that the proposed rule will have any economic effect on public utilities or their rate payers.
Fiscal Estimate
Attached is the Fiscal Estimate and Economic Impact Analysis.
Effect on Small Business
Attached is the Initial Regulatory Flexibility Analysis.
Agency Contact Person
Chad Zadrazil, Program and Policy Analyst – Advanced, Department of Safety and Professional Services, Division of Board Services, 1400 East Washington Avenue, Room 151, P.O. Box 8935, Madison, Wisconsin 53708; telephone 608-266-0011; email at
chad.zadrazil@wisconsin.gov.
Initial Regulatory Flexibility
Proposed Order
An order of the Pharmacy Examining Board to create Chapter
Phar 18, relating to the prescription drug monitoring program and affecting small business.
Background
Under
2009 Act 362, the legislature directed the Wisconsin Pharmacy Examining Board (Board) to create through rule a prescription monitoring program. The proposed rule fulfills the legislative directive by establishing a prescription drug monitoring program (PDMP) to collect and maintain data regarding the prescribing and dispensing of monitored prescription drugs. The monitored prescription drugs are federally controlled substances in Schedules II-V, state controlled substances in Schedules II-V, as amended by the Controlled Substances Board, and Tramadol, a drug identified by the Board as having a substantial potential for abuse. A controlled substance that can be legally dispensed without a prescription order is not a monitored prescription drug under the proposed rule.
In general, the proposed rule requires dispensers to compile and submit to the Board data about each time they dispense a monitored prescription drug within 7 days. The proposed rule also requires dispensers to submit reports to the Board for each 7-day period during which he or she does not dispense a monitored prescription drug.
Under the proposed rule, the Board may waive the 7-day reporting requirements for dispensers who only dispense monitored prescription drugs to non-human animal patients. Instead, the dispensers would be required to submit the required data or report indicating that they have not dispensed a monitored prescription drug every 90 days.
The proposed rule requires dispensers to submit the data to the Board electronically, in the standard established by the American Society for Automation in Pharmacy's Implementation Guide for Prescription Monitoring Programs.
Under the proposed rule, the Board may grant waivers to dispensers who are not able to comply with the 7-day reporting or the electronic data submission requirements. Therefore, dispensers who are not able to comply with one or both of the reporting or submission requirements may submit to the Board an application for a waiver.
The proposed rule requires the Board to develop and maintain a database to store all of the data submitted to it as part of the PDMP. Practitioners and dispensers will be able create accounts with the Board to access the database and view information that may be helpful in determining whether a patient is using any of the specific prescription drugs illicitly. Further, under the proposed rule, other entities, such as law enforcement authorities, patients and staff of the Department of Safety and Professional Services, may create accounts to request data from the Board as permitted under s.
146.82, Stats.
Types of small businesses affected by the rule
The proposed rule will affect small businesses, as defined in s.
227.114 (1), Stats., that dispense monitored prescription drugs. As pharmacies dispense most of the monitored prescription drugs in Wisconsin, pharmacies and pharmacists would be most affected by the rule. Still, as the proposed rule also requires health care practitioners that dispense monitored prescription drugs to submit information regarding each dispensing of a monitored prescription drug to the PDMP, some health care practitioners will also be affected. Health care practitioners are physicians, advanced practice nurses, dentists, optometrists and veterinarians. Therefore, the proposed rule will affect community pharmacies, other small pharmacies and pharmacists and practitioners that practice medicine within a small business.
Proposed reporting, bookkeeping, and other procedures required for compliance with the rule
The proposed rule requires pharmacies, pharmacists and health care practitioners that dispense monitored prescription drugs to submit information regarding each dispensing of a monitored prescription drug to the PDMP in the electronic format identified by the American Society for Automation in Pharmacy's (ASAP) Implementation Guide for Prescription Monitoring Program. The format identified by ASAP is the standard used by all operational state prescription monitoring programs. It defines the required data elements and acceptable inputs, which enables state prescription monitoring programs to share data with one another more easily.
The data elements identified in the proposed rule comply with the ASAP format. Therefore, to comply with the proposed rule, pharmacies, pharmacists and health care practitioners are required to compile and submit the following information to the PDMP within seven days of dispensing a monitored prescription drug:
•
dispenser's full name;
•
dispenser's NPI number or DEA registration number;
•
date dispensed;
•
prescription number;
•
name and strength of the prescription drug;
•
NDC number;
•
quantity dispensed;
•
estimated number of days of drug therapy;
•
practitioner's full name;
•
practitioner's NPI number or DEA registration number, if applicable;
•
date prescribed;
•
quantity prescribed;
•
patient's full name;
•
patient's address, including street address, city, state and ZIP code;
•
patient's date of birth; and
•
patient's gender.
