Contact: Richard Gulla
Issues strong support for some proposals; calls others inappropriate
Waltham/Boston – July 30 – Saying that a prescription monitoring program is “one of the best available tools to fight prescription drug abuse,” the Massachusetts Medical Society (MMS) today offered testimony before the Department of Public Health on proposed regulations for the state’s Prescription Monitoring Program (PMP), telling health officials that “while a monitoring program can be a powerful tool, it should not become a barrier to the practice of good medicine or access to comprehensive care.”
The Massachusetts Medical Society, the professional association of physicians with nearly 25,000 members across the Commonwealth, helped to establish the state’s monitoring program more than 20 years ago and remains one of its strongest supporters as a tool to fight prescription drug abuse.
In a commentary posted on the Society’s website earlier this month, MMS President Richard Pieters, M.D., said that the state’s prescription monitoring program “has yet to fulfill its promise” and that the monitoring program “should be regarded as a cornerstone of our collective efforts to address prescription drug abuse. It’s time for that to happen, and physicians stand ready to help.”
In today’s testimony, MMS declared its support for many of the proposed regulations, yet also cautioned DPH officials that “the proposed regulations go too far in many areas where a more measured, evidence-based approached is warranted.”
The Society’s testimony cited specific areas of the proposed regulations:
Requiring Use Prior to Issuing Prescription for First Time
The Society said it believes that the PMP is a tool that should be available for use by prescribers and dispensers “at their professional discretion.” “The primary purpose of creating a database and funding a state agency to operate the database,” the MMS said, “is to allow analysis of data on a large scale to identify individual patients, prescribers, and dispensers with potential issues, not to enlist all prescribers in screening all patients about to receive opiate and benzodiazepine prescriptions.”
MMS suggested that the DPH start mandatory use with opiates, to judge whether the computers will accommodate increased demand for the database, to determine the clinical impact of the program on opiate overdoses and addiction, and to see whether a detrimental impact on patients will result.
Exemptions from Use of the PMP The Society said it supports proposed, expanded exemptions from use of the PMP for several categories, including hospice patients, small amounts of prescriptions in emergency departments, inpatients, immediate treatment, children under 48 months, and times when it would be impossible to use the program.
MMS also stated its support of waivers for those unable to meet the requirements of the regulations for financial or other reasons. “To remove a physician from prescribing practice who has no history of complaints, substandard care, or overprescribing simply because of non-compliance with the proposed regulations,” MMS said, “is detrimental to the public health and a waste of human resources.”
Use of Delegates to Support Prescribers
The Society’s testimony issued its strong support of the use of delegates to make the PMP an efficient clinical tool and to make the designation of “as many delegates as needed by practitioners as simple as possible.” The Society also urged that the proposed regulations providing for delegates should be rewritten, as they “create an intimidating and cumbersome process as written to protect against confidentiality breaches which are theoretical and are already subject to severe penalties under state and federal law.”
Disciplinary Actions by DPH
The Society strongly objected to proposed provisions giving DPH authority to discipline prescribers by suspending or revoking their right to prescribe. “There is no statutory basis or legal precedent,” MMS noted, “for the DPH or its Drug Control Program having any authority or ability to deny a fully licensed prescriber the right to practice under their state license.” The MMS strongly suggested that any violations of its program rules must be referred to an appropriate licensing agency, such as the Board of Registration in Medicine, for determination of facts and issuance of sanctions.
Proposed regulations give the DPH authority to deny a prescriber the right to issue prescriptions simply based on use of the PMP “in a manner inconsistent with the terms and conditions for such use.” Calling this proposed regulation “beyond draconian,” MMS said “it is neither necessary nor appropriate for the Department to take these powers on for itself.”
Use of Audits
The proposed regulations reference the use of audits at the arbitrary discretion of the DPH as a way to initiate disciplinary actions. “The Department should utilize its limited staff and resources to working with the medical review board to review data in a manner consistent with the primary purpose of the prescription monitoring program,” the MMS wrote. “The MMS urges the Department not to follow this punitive and intimidating model.”
Automatic Registration of Prescribers and Dispensers
The MMS testified that the proposed regulations directly conflict with specific state law and urged the DPH to “follow state law and automatically issue registration and access codes to all practitioners with prescribing and dispensing authority.”
Inclusion of Prescribers
As originally written, the regulations only applied to physicians, dentists, and podiatrists, and not nurse practitioners. The MMS supported the DPH’s acceptance of the inclusion of “all prescribers except veterinarians in the program.”
In concluding its testimony, the Society said “A well-run PMP has four purposes: (1) identifying patients who get schedule II and III prescriptions from multiple doctors; (2) identifying prescribers who inappropriately write many prescriptions or write prescriptions for high dosages; (3) providing a clinical review of those patients and prescribers, to determine what interventions might be necessary; and (4) facilitating research in discovering trends, practices, and problems.
“To achieve those advantages, however, all prescribers must participate, and the program must accommodate real-time data,” MMS said.
“We also believe DPH should resurrect its medical review board, created as part of the original PMP but subsequently underutilized. This board can initiate and approve research as well as determine patterns that may indicate abuse and propose needed interventions and refer such activity to appropriate licensing boards.”
The Medical Society’s complete testimony is available at www.massmed.org/testimony
The Massachusetts Medical Society, with more than 24,000 physicians and student members, is dedicated to educating and advocating for the patients and physicians of Massachusetts. The Society, under the auspices of NEJM Group, publishes the New England Journal of Medicine, a leading global medical journal and web site, and NEJM Journal Watch alerts and publications covering 13 specialties. The Society is also a leader in continuing medical education for health care professionals throughout Massachusetts, conducting a variety of medical education programs for physicians and health care professionals. Founded in 1781, MMS is the oldest continuously operating medical society in the country.