PUBLIC HEALTH COUNCIL

A regular meeting of the Massachusetts Department of Public Health’s Public Health Council was held on Tuesday, September 19, 2006, 10:00 a.m., at the John W. McCormack Building, One Ashburton Place, 21st Floor conference room, Boston, Massachusetts.  Members present were:  Chair Paul J. Cote, Jr., Commissioner, Department of Public Health, Atty. Michael C. Hanson, (arrived late during the staff presentation), Ms. Soo J. Kim, Atty. Jennifer A. Nassour, Ms. Maureen Pompeo, Mr. Albert Sherman, and Martin J. Williams., M.D.  Clifford Askinazi, M.D and Mr. Gaylord Thayer, Jr., were absent.  Also in attendance was Attorney Donna Levin, General Counsel, Department of Public Health.

Chair Cote announced that notices of the meeting had been filed with the Secretary of the Commonwealth and the Executive Office of Administration and Finance.

The following members of the staff appeared before the Council to discuss and advise on matters pertaining to their particular interests:  Commissioner Paul J. Cote, Dept. of Public Health, and Ms. Joan Gorga, Director, Determination of Need Program.

RECORD OF THE PUBLIC HEALTH COUNCIL MEETING OF AUGUST 29, 2006:

A Record of the Public Health Council Meeting of August 29, 2006 was presented to the Public Health Council for approval.  After consideration, upon motion made and duly seconded, it was voted unanimously to approve the Record of the Public Health Council Meeting of August 29, 2006 as presented.

STAFF PRESENTATION:  “FROM INFORMATION TO ACTION:  THE CASE OF PRESCRIPTION OPIOID ABUSE”:  by Paul J. Cote, Jr., Commissioner, Dept. of Public Health:

Commissioner Cote, Chair, Public Health Council, said in part, “Some of the Council Members have previously requested a discussion on the various data that is presented to the Council, to have a discussion and a demonstration as to how that epidemiological data actually is translated into action, in fact, any type of programmatic planning such, if when we have a death report which outlines numerous data, in particular specific to today’s discussion, where you have poisonings, and specifically poisonings as related to opioids, what types of programmatic action ensues after that type of information is brought to us.”

He continued, “What we are going to be following, I think, for the Public Health Council’s benefit, is really the process that takes place, and it is a continuous process.  It is one where you actually have surveillance which is essentially the presentation of raw data, such as birth reports, death reports, etc…the connections that people do not see between those reports and the action that takes place is the type of trend analysis and risk identification that takes place with the experts within the Department, within the various program elements.  That activity leads to the development of a strategic plan, policy development, as well as program design, which in turn feeds into implementation activities that carry with them an essential part of assessment evaluation and continuous improvement so that you actually see the ongoing and continuous nature of our analysis and planning efforts.  What I hope people will see, as we proceed through this discussion, and obviously in any subsequent discussions relative to reports to the Public Health Council, is how the Department of Public Health’s mission statement actually is reinforced by both the analysis as well as the program planning that ensues as a result of that analysis….”

Slides were shown indicating the information that can be obtained from various sources: 
From Death reports:

•	The incidence of hospitalizations credited to opioid-related activities for residents from 1994 to 2004 increased by almost 100%.  This activity is more substantial in males than females
o	Provides the Department the information needed to target what age groups and what gender programs need to be geared to

•	Fatal overdoses that are opioid-related had a dramatic increase of over 500% between 1990 and 2004, in comparison, other poisonings increased by about 10%.

o	Data indicates that the Department should focus attention in this area.

Illicit Drug Users:

•	Marijuana, once the leading initiate of choice for illicit drugs among new users, has been replaced with non-medical use of prescription pain relievers , the incidence of non-medical use of prescription drugs being higher than Marijuana since 2002 (76% of all initiates to illicit drugs are associated with pain relievers).

•	In 2005, 9.9% of the youths age 12 to 17 were current illicit drug users --6.8% of them used marijuana; 3.3% used prescription type drugs non-medically, and 1.2% used inhalants; .8% used hallucinogens, and .6% used cocaine.  The overall rate of current illicit drug use among youths twelve to seventeen in 2005 was significantly lower than that in 2002.  The rate went from 11.6% in 2002 to 9.9% in 2005.  

o	Data above leads to development of a Strategic Plan and the core elements of the plan are (Three Key Strategies):

•	Enhance our surveillance and monitoring program 

•	Education and Training

•	Prevent, Intervene, and Treat using Best Practices

Linkage of Strategies Consistent with MA Substance Abuse Strategic Plan

•	Addiction is recognized and dealt with as a chronic disease.

•	Potential users receive prevention services before they ever use.

•	Effective interdiction and enforcement efforts reduce the availability and the pervasive impact of drugs.

•	People needing treatment and/or other interventions are identified early, effectively and efficiently.

•	Individuals receive effective assessments and are consistently placed in the most appropriate levels of care.

•	A continuum of services, with supply corresponding to appropriate demand, is available and is well managed.

•	Prevention, treatment and support services are timely, appropriate and effectively delivered.

•	Reducing substance abuse and addiction is a government and community-wide fight.  Each has important role to play.

Commissioner Cote noted, “One of the key things that people need to know in fighting abuse of the non-medical use of pain relievers, it is critical for us to work with children and their families to delay the onset of alcohol abuse.  We know this is a critical marker because it is recognized that early drinking and the use of tobacco are directly related to later substance abuse issues.  We also are focusing on parental education because many of the young adults who are getting prescription drugs are getting them from the homes of their families and friends.”

Commissioner Cote further stated that a major focus of the Strategic Plan is on early identification and intervention.  “The greatest predictor of successful treatment for individuals with substance abuse is in the length of stay in treatment that individuals attain, so that it is of critical importance for us to expand our continuum of care in order to provide various levels of services so we can sustain individuals in treatment and, ultimately have a great success rate with helping individuals deal with their addiction.  Also through this expanded continuum of care, we are not only able to provide individuals with greater treatment options, but it also increases their access to those services, which is key.”

The Prescription Monitoring Program (Department’s Drug Control Program):

•	120% increase in Schedule II opioid prescriptions over nine years, from 800,000 in FY96 to 1.8 million in FY05.  This was a result of both a 60% increase in the estimated number of individuals receiving Schedule II opioid prescriptions, as well as a 40% increase in the average number of Schedule II opioid prescriptions dispensed per individual.  

•	PMP data can clearly identify, the number of oxycodone prescriptions that are dispensed, and the number of days that they actually being dispensed to one customer during a particular month from multiple physicians and multiple pharmacies.

o	Data indicates diversion and abuse of opioid prescriptions -- doctor shopping

o	Development of strategic plan

Commissioner Cote said the Prescription Monitoring Program (PMP) has to balance the goals of ensuring pharmaceuticals are available for medical use and on the other hand prevent drug diversion, prescription fraud, illicit use and abuse.   The PMP is a tool for use in addressing prescription drug diversion, prescription data is collected from dispensers, then the data is reviewed and analyzed by the Department, and reports are then provided to authorized end users.  The goals of the PMP are education and information, to identify and pursue public health initiatives, to achieve early intervention and prevention, supporting investigations and enforcement activities, and provide protection of confidentiality of individuals within the system.

As a result of this data collection, the Massachusetts PMP is implementing various enhancements:

•	Meet or exceed national standards for data fields reported
•	Require positive identification for Schedule II prescriptions
•	Initiate provision of reports to practitioners and pharmacies (MA is taking a lead role in developing a resource toolkit, created by practitioners for practitioners)
•	Develop epidemiological tracking sytem for medical and non-medical use of opioids
•	Facilitate interstate sharing of information (MA is taking a lead role in New England)
•	Collaborate with community-based effort (Berkshire Health Systems)

Future Considerations for PMP Enhancement:

•	Expand data reporting beyond Schedule II
•	Require positive ID for other Schedules
•	Provide on-line, real-time access (e.g., Kentucky)
•	Streamline access by law enforcement
•	Expand epidemiological tracking system (e.g., generate community-based analyses)
•	Provide information to substance abuse treatment agencies
•	Coordinate with other prescription database objectives, for example
o	Provide ED access to prescription history
o	Serve as repository for prescription information in a large-scale emergency
o	Establish interstate interoperability

Commissioner Cote stated, “I think it is important to note that any type of activity around expanding this, all are materials which would follow our Public Health Council, our public policy and regulatory process where, before we would even consider this, we would work with our various interest groups, our legislators, as well as our policy directors, to make sure that we are on track.  This is exactly the kind of thing which, if there were going to be changes recommended, they would come up as recommended policies.  They would have a public hearing and, ultimately, would go through any type of a revision necessary before they became regulation.”

Commissioner Cote elaborated, “I think other enhancements and future considerations that we would also make, based upon the information that we have seen and our ability to track the success of the Prescription Monitoring Program, is that we do believe, the ability to make this information available to substance abuse treatment agencies I think would be invaluable in terms of being able to have a coordination of care and a comprehensive view of the individual that we are trying to serve.  The idea of us being able to coordinate with other prescription databases, for example, provide emergency departments access to this prescription history, could be invaluable.  One of the key places where individuals actually present with pain, looking, seeking medication, is at the emergency departments, and this would be a key tool in order to help them identify individuals that might be engaged in inappropriate drug seeking behavior.  The idea of being able to serve as a repository for prescription information in the form of a large scale emergency would be invaluable.  The fact that we would have this data available in a single place would have a tremendous utility.  I also think the idea of us being able to move towards some type of a system where we would be able to have what is referred to as interoperability or exchange among states because the activity of drug seeking behavior clearly does not necessarily limit itself to within state boundaries.  Clearly, the idea of being able to share information across states would be quite helpful….”

In closing, Commissioner Cote said, “This has been our first attempt to try to show the interdependence of both the surveillance activity, the data that is reported to the Public Health Council on a regular basis, how it fits with the ultimate plans that are developed, and how those plans are developed, implemented, evaluated, and assessed for changes and correction as necessary, and ultimately how that leads to, and we can track, potential changes in data and future trends in a continuous process.”

No Vote/Information Only

DETERMINATION OF NEED PROGRAM:

REGULATION:

REQUEST FOR FINAL PROMULGATION OF AMENDMENT TO 105 CMR 100.000:  DETERMINATION OF NEED REGULATIONS GOVERNING FILING DAYS FOR APPLICATIONS FOR INNOVATIVE SERVICES AND NEW TECHNOLOGY (FILING DATES FOR RADIATION THERAPY PROJECTS):

Ms. Joan Gorga, Director, Determination of Need Program, presented the request for final promulgation of proposed amendment to regulations governing filing days for applications for innovative services and new technology.  She said in part, “…On July 25, 2006, the Council adopted the emergency amendment to delay the filing date of applications for Megavoltage Radiation Therapy Units from the first business day of August 2006 to the first business day of October 2006.  The emergency promulgation was necessary because the Department revised the Guidelines for Megavoltage Radiation Therapy Services and presented them to Council for approval on July 25, 2006.  Thus, the Guidelines were not completed in time for applicants to adequately plan for and prepare applications for the August 2006 filing day for Radiation Therapy applications.”

Ms. Gorga said further, “The Department held a public hearing on August 21, 2006 in the Daley Conference Room, 5th floor, 2 Boylston Street, Boston, MA.  No one attended the hearing and no written comments were received.  The Department asks that this amendment be approved for final promulgation as presented today.  Following your approval, the Department will file a Notice of Compliance with the Secretary of the Commonwealth to make the emergency amendment permanent.”

After consideration, upon motion made and duly seconded, it was voted unanimously to approve Final Promulgation of Amendment to Determination of Need Regulations 105 CMR 100.000 Governing Filing Days for Applications for Innovative Services and New Technology; that a copy be forwarded to the Secretary of the Commonwealth for promulgation; and that a copy be attached and made a part of this record as Exhibit No. 14,867.  This amendment allows for the following:

105 CMR 100.000 is amended by revising 105 CMR 100.302F as follows: New Language is indicated by shading

100.302	Filing Days for Applications and Amendments

(F)	The filing days for applications for innovative services or new technologies shall be the first business days of February and August; provided, however, that
(1) the filing day for applications for Neonatal Care units shall be the first business day of August 2007 and thereafter the filing day for such applications shall be the first business days of February and August; and
(2) the filing day for applications for Radiation Therapy Units shall be the first business day of October 2006 and thereafter the filing day for such applications shall be the first business days of February and August.

Chair Cote made an announcement noting that the “Statewide Pandemic Media Campaign” on influenza will be launched October 4, 2006 at the State Laboratory Institute in Jamaica Plain.  He said the campaign will alert individuals in terms of what they can do for themselves as well as issue Public Service Announcements.

The meeting adjourned at 10:55 a.m.

						____________________
LMH/lmh					Paul J. Cote, Chair