Notice of Hearing

Safety and Professional Services

Pharmacy Examining Board

CR 12-009

NOTICE IS HEREBY GIVEN that pursuant to sections 15.08 (5) (b), 227.11 (2) (a), 450.19 (2) and (5), 961.31, Stats., and interpreting Chapters 450 and 961, Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to create Chapter Phar 18, relating to the prescription drug monitoring program and affecting small business.

Hearing Information

Date:	Monday, February 27, 2012
Time:	8:00 A.M.
Location:	1400 East Washington Avenue Room 121 A, B & C Madison, WI 53703

Appearances at the Hearing and Submittal of Written Comments

Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and arguments in writing as well. Facts, opinions and arguments may also be submitted in writing without a personal appearance by mail addressed to:

Chad Zadrazil
Department of Safety and Professional Services
Division of Board Services
P.O. Box 8935
Madison, Wisconsin 53708-8935

Written comments must be received before 8:00 a.m. on February 27, 2012, to be included in the record of rule-making proceedings.

Copies of Proposed Rule, Fiscal Estimate, Economic Impact Analysis and Initial Regulatory Flexibility Analysis

Copies are available upon request to Chad Zadrazil, Department of Safety and Professional Services, Division of Board Services, 1400 East Washington Avenue, P.O. Box 8935, Madison, Wisconsin 53708-8935 or by email at chad.zadrazil@wisconsin.gov.

Analysis Prepared by the Department of Safety and Professional Services

Statutes interpreted

Chapters 961 and 450, Stats.

Statutory authority

Sections 15.08 (5) (b), 227.11 (2) (a), 450.19 (2) and (5), 961.31, Stats.

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

Section 146.82, Chapters 450 and 961, Stats., and Chapters Phar 1 and 8 and Chapter CSB 2.

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.

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.

As of December 5, 2011, there are 1,279 licensed pharmacies in Wisconsin according to the Department of Safety and Professional Services' database. According to the Department of Health Services (DHS), only 17 pharmacies in the state of Wisconsin are not capable of receiving electronic prescription orders. Therefore, the type of business most affected by the compliance requirements of the proposed rule is not expected to incur significant costs to comply with the proposed rule.

The use of EHR is also prevalent among physicians and other health care practitioners in large group practice. According to DHS, approximately 74% of physicians are in large group practice and almost all of them utilize electronic health records (EHR).

Conversely, the use of EHR is not as prevalent among veterinarians. According to the Wisconsin Veterinary Medical Association, approximately 273 of the 719 veterinary clinics in Wisconsin are able to access prescription information electronically.

Understanding that the use of EHR varies among types of businesses and health care practitioners, the Board developed the proposed rule to allow the submission of data to the PDMP in multiple ways.

If a pharmacy, pharmacist or health care practitioner currently utilizes EHR, they can comply with the requirement to submit data electronically in the proposed rule is to program their current prescription dispensing software to automatically collect and submit the data to the PDMP. Likely, there would be an up-front cost associated with the computer programming as it may require hiring a computer programmer or software vendor to make the necessary changes. However, there would not be any significant ongoing personnel costs required to maintain compliance with the proposed rule.

A pharmacy, pharmacist or health care practitioner who does not currently utilize EHR can comply with the requirement to submit data electronically in the proposed rule by manually submitting the data to the PDMP. Manual submission can still be accomplished electronically through an online account established with the Board, through secure email or mailing of compact disks that contain the data.

Further, if a pharmacy, pharmacist or health care practitioner does not have access to a computer or is otherwise unable to compile or submit data by any electronic means, they may apply for a waiver from the Board. Once waived, the pharmacy, pharmacist or health care practitioner would be able to submit data on paper to the PDMP.

By choosing a method that does not require computer programming and software development, there are no up-front compliance costs to retrofit computer software. However in order to maintain compliance, a pharmacy, pharmacist health care practitioner or a delegate must manually submit data regarding each dispensing of a monitored prescription drug within seven days of dispensing it. Therefore, the pharmacy, pharmacist or health care practitioner would incur personnel costs associated with compiling and submitting data to the PDMP.

By default, the proposed rule requires the submission of data within seven days of dispensing a monitored prescription drug or, if no monitored prescription drugs were dispense in a seven-day period, seven days from the previous data submission. Therefore, most pharmacies, pharmacists and health care practitioners that dispense a monitored prescription drug would be submitting data at least every seven days.

The proposed rule lessens the reporting burden on veterinarians who solely dispense monitored prescription drugs to non-human animal patients by allowing them to apply for a waiver from the seven-day reporting requirements. Instead, the veterinarian would be required to submit data to the PDMP every 90 days.

Under the proposed rule, a pharmacy, pharmacist or health care practitioner that does not dispense the monitored prescription drugs may apply for a complete exemption from the reporting requirements. The proposed rule associates the expiration of the exemption to licensure renewal to eliminate the administrative burden that applying for an exemption may have created. Under the proposed rule, the exemption would last until licensure renewal or until the pharmacy, pharmacist or health care practitioner dispenses a monitored prescription drug. Therefore, a pharmacy, pharmacist or health care practitioner applying for the exemption can indicate so as part of the licensure renewal process. There would be no compliance requirements or associated costs incurred by exempt pharmacies, pharmacists and health care practitioners.

Types of professional skills necessary for compliance with the rule

The proposed rule would not require a pharmacy, pharmacist or health care practitioner to obtain any professional skills beyond those common among the professions.

STATE OF WISCONSIN

DEPARTMENT OF ADMINISTRATION

DOA 2049 (R 07/2011)

ADMINISTRATIVE RULES

FISCAL ESTIMATE AND ECONOMIC IMPACT ANALYSIS

Type of Estimate and Analysis

X Original

Updated

Corrected

Administrative Rule Chapter, Title and Number

Wis. Admin. Code Chapter Phar 18

Subject

Prescription drug monitoring program

Fund Sources Affected

GPR

FED

X PRO

PRS

SEG

SEG-S

Chapter 20 , Stats. Appropriations Affected

20.165 (1) (g) and 20.165 (1) (h) (g)

Fiscal Effect of Implementing the Rule

No Fiscal Effect

Indeterminate

Increase Existing Revenues

Decrease Existing Revenues

X Increase Costs

Could Absorb Within Agency's Budget

Decrease Costs

The Rule Will Impact the Following (Check All That Apply)

State's Economy

Local Government Units

X Specific Businesses/Sectors

Public Utility Rate Payers

Would Implementation and Compliance Costs Be Greater Than $20 million?

Yes

X No

Policy Problem Addressed by the Rule

The proposed rule implements the legislative mandate in 2009 Wisconsin Act 362, which directs the Pharmacy Examining Board to establish through rule a prescription drug monitoring program. The primary purpose of the prescription drug monitoring program is to decrease the illicit use of prescription drugs and the resulting social, health care and law enforcement costs. As noted in a 2011 report issued by the Executive Office of the President of the United States, "Epidemic: Responding to America's Prescription Drug Abuse Crisis," prescription drug abuse is the country's fastest-growing drug problem.

According to the National Survey on Drug Use and Health (NSDUH), nearly one-third of people age 12 and over who used drugs for the first time in 2009 began by using a prescription drug non-medically ("Results from the 2009 National Survey on Drug Use and Health: National Findings," SAMHSA, 2010). The same survey also states that the vast majority of people abusing prescription pain relievers (over 70%) got those drugs from friends or relatives. The "Monitoring the Future" study - which surveys drug use among young people - showed that prescription drugs are the second most-abused category of drugs after marijuana ("Monitoring the Future: A Synopsis of the 2009 Results of Trends in Teen Use of Illicit Drugs and Alcohol," University of Michigan).

Given the recent report from the President's office and other sources of data, it is clear that prescription drug abuse is a serious problem in America and it is a problem that has grown over the last decade. Wisconsin's problems mirror the nation's, with prescription drug abuse encompassing such activities as "doctor shopping" to obtain multiple prescriptions, illegal sales of prescription drugs by prescribers, and prescription forgery. Wisconsin's prescription drug abuse rate is on par with the national average, with 5.83% of state residents age 12 and older reporting use of pain relievers for non-medical purposes in 2005-06 (SAMHSA 2007; WIDHS 2008).

It has been estimated that, in 2010, there were roughly 297,331 abusers in Wisconsin. The social costs of drug abuse include decreased productivity and absence from work, increased health care costs, and increased law enforcement costs (Birnbaum, H., et al., 2006, "Estimated Costs of Prescription Opioid Analgesic Abuse in the United States in 2001," Clinical Journal of Pain. 22(1): 667-676).

Summary of Rule's Economic and Fiscal Impact on Specific Businesses, Business Sectors, Public Utility Rate Payers, Local Governmental Units and the State's Economy as a Whole (Include Implementation and Compliance Costs Expected to be Incurred)

There will be ongoing staff costs related to monitoring and administering the program. DSPS will have the need for a full-time program and planning analyst to monitor the program and work with the vendor and others to manage the program. Further, there will be ongoing costs for a vendor to host and maintain the PDMP database, website and other related IT components of the PDMP. Based on the annual costs incurred by similar prescription monitoring programs in other states, we anticipate annual costs of approximately $210,000.

While the health care sector will 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.

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. 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.

The two comments about the economic impact on veterinarians present differing estimates on the impact to the profession. The first comment, from Dr. Richard Spencer, the Chairperson of the Wisconsin Veterinary Examining Board, estimates that it would take a staff person one to two hours to compile and submit the required information to the PDMP and cost between $30 and $60 per submission. Dr. Spencer also states that he would likely cease dispensing monitored prescription drugs and merely prescribe them to be dispensed by a pharmacist.

The other comments regarding the economic impact of the proposed rules on the veterinary profession are from the Wisconsin Veterinary Medical Association (WVMA). The WVMA estimates that the yearly impact on veterinarians would be $7,953,816, or approximately $11,000 of direct personnel costs and lost revenue for each of the 719 veterinarian clinics in Wisconsin as of December 2011. The estimate is based on the assumption that it would take approximately 4.5 hours per week to comply with the requirements of the proposed rule for a clinic with some electronic health records and 6.5 hours per week to comply for clinics without any electronic health records.

The department sought further information regarding the WVMA's assumptions in their analysis. The department has yet to receive any further information. Specifically, the department asked for further information regarding:

- the estimated number of times per week, on average, that veterinarians dispense a monitored prescription drug from their clinic and how it estimated the number;

- the basis for assuming that that it will take a clinic 4.5 hours per week, on average, for clinics with some type of electronic records to comply with the requirements in the draft rules; and

- the basis for assuming that it will take a clinic 6.5 hours per week, on average, for clinics without any electronic records to comply with the requirements in the draft rules.

The department believes the information is required to estimate the proposed rule's economic impact on the veterinary profession and will continue to search for it. Without having information regarding the number of times veterinarians dispense the monitored prescription drugs, the department has no way to validate or calculate Dr. Spencer's or the WVMA's estimate economic impact.

Further, the proposed rule already includes a less stringent compliance and reporting requirements for veterinarians, including less stringent schedules for compliance reporting requirements. Specifically, the proposed rule enables the Board to waive the 7-day reporting requirements for dispensers who solely dispense to non-human animal patients. Under the terms of the waiver, veterinarian dispensers would be required to submit data to the PDMP every 90-days.

Finally, the proposed rule includes an exemption from all compliance requirements of the rule for pharmacies, pharmacists and health care practitioners that do not dispense any of the monitored prescription drugs. To make the administrative burden as small as possible, the proposed rule relates the application for an exemption to licensure renewal. Therefore, the pharmacies, pharmacists and health care practitioners that do not dispense any of the monitored prescription drugs will not have any additional filing requirements or deadlines.

Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule

The benefit of implementing the proposed rule is to ultimately lessen the occurrences of prescription drug diversion, the illicit use of prescription drugs in Wisconsin and resulting social, health care and law enforcement costs. The proposed rule creates a tool that will enable the approximately 50,000 pharmacies; pharmacists; practitioners, including physicians, dentists and veterinarians; law enforcement agencies and public health officials to obtain invaluable information to assist in their efforts to curb prescription drug abuse in Wisconsin. Further, the proposed rules are in conformity with legislative directive in 2009 Wisconsin Act 362. An alternative to implementing the rule is to not comply with legislative directive in 2009 Wisconsin Act 362 and to not monitor the dispensing of controlled substances across the state.

Long Range Implications of Implementing the Rule

The anticipated long range results of implementing the proposed rule are a reduction in the non-medical use of controlled substances and other prescription drugs that have a substantial potential for abuse and reduction in related social, health care and enforcement costs. The reductions will be due to the ability of practitioners and dispensers to ensure that their patients are not "doctor shopping" or undertaking other activities associated with the non-medical use of prescription drugs.

Compare With Approaches Being Used by Federal Government

There is no existing or proposed federal regulation comparable to the proposed rule.

Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota)

The proposed rule is similar to the approaches being used by Illinois, Iowa, Michigan and Minnesota, who currently have operational prescription monitoring programs. In addition, 36 other states currently have operational prescription monitoring programs similar to the one established by the proposed rule.

Name and Phone Number of Contact Person

Chad Zadrazil, Program and Policy Analyst - Advanced, 608-266-0011