Rule-Making Notices (Hearing Notices)

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.

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			Chapter 20 , Stats. Appropriations Affected
GPR FED X PRO PRS SEG SEG-S			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