Frequently Asked Questions (FAQ)
1. What states have prescription monitoring programs?
According to the Drug Enforcement Administration, as of January 2010, 34 states have operational PDMPs that have the capacity to receive and distribute controlled substance prescription information to authorized users. States with operational programs include: Alabama, Arizona, California, Colorado, Connecticut, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, West Virginia, and Wyoming. Six states (Alaska, Florida, Kansas, Oregon, Washington and New Jersey) and one U.S. territory (Guam) have enacted legislation to establish a PDMP, but are not fully operational. See chart 1.
2. Is the program proposed for Florida in compliance with the federal Health Insurance Portability and Accountability Act (HIPAA)?
Yes. In fact, Florida’s PDMP will meet all the security requirements required of the Florida Department of Health which are more stringent than HIPAA requirements. See chart 3 for required Project Manager validation of request.
3. Isn’t the accessibility to controlled substance prescription data a violation of patient confidentiality?
The entire program will be federal Health Insurance Portability and Accountability Act (HIPAA) compliant. The access of the patient’s prescription history, when a state has authorized a PDMP, is authorized under HIPAA.
The Florida PDMP provides safeguards to protect patient confidentiality and access to controlled substance prescription information through statute. The law prohibits unauthorized access to and use of confidential patient information. Any person who willfully and knowingly violates this law commits a felony of the third degree.
The entire prescription history of all patients in Florida, even beyond the Schedule II – IV drugs specified by the program, is currently available in many different locations in the private sector. Currently complete prescription information quite often resides in the local pharmacy computer database, the pharmacy’s regional headquarters database, and the pharmacy’s national headquarters database. Moreover, the health insurance companies and their agents who pay for medications quite often maintain the same information in a database. The PDMP mandates more stringent controls on prescription history and, in fact, imposes much greater penalties for unauthorized disclosures than anywhere in any of the many private sector databases.
4. Who will have access to the information stored in the statewide database?
- Health care practitioners (pharmacists and physicians) who have registered with the Department of Health and have been validated as licensed practitioners in the state of Florida
- The following entities may request access through the database’s program manager (PM). The PM must ensure the validity of the request prior to providing the information to:
- Appropriate medical regulatory board
- Attorney General’s Medicaid Fraud Unit
- Law enforcement (defined as Florida Department of Law Enforcement, Florida Sheriffs’ Offices and Florida Police Departments)
- Patients to verify their prescription history
- Department of Health: non-identifying information for annual report on performance measures
- Implementation and Oversight Task Force: non-identifying information for annual report
5. What are the annual costs to operate a prescription-monitoring program?
The cost of implementing and operating a prescription-monitoring program vary depending upon the type of system that is authorized by that particular state to include but not all of the functions; number of health care practitioners, volume of dispensed prescriptions, use of in-house and out-sourced functions, etc. Florida estimates that its system may cost $480,000 dollars to purchase and initially operate the system for one year. Annual operating costs after that are estimated to be $450,000 per year.
6. What are some of the beneficial uses of the PDMP?
Prescription drug monitoring programs can be used to improve patient standard of care by:
- Allowing physicians to access the database for their patients and determine if their patient has been prescribed controlled substances from other physicians that might negatively interact when used together. It also allows the physician to prescribe controlled substances that will not negatively interact with medicines prescribed by other physicians.
- Allowing pharmacists to access the database for their patients and determine if their patient has been prescribed controlled substances from physicians that might negatively interact when used together.
- Allows health care practitioners (doctors/pharmacists) to access the database for their patients and determine if their patient has had multiple prescriptions for the same drugs from different doctors. This helps identify those patients potentially engaged in the crime of "doctor shopping" (which is a felony in Florida). This assists health care professionals in their practice and allows them to intervene on their patient’s behalf and assist them in obtaining treatment, if they are addicted.
- When a potential illegal diversion pattern for drugs is identified by the database and doctors/pharmacists have requested the information, the information through a Patient Activity Report (PAR) is then disseminated to the doctors and pharmacists alerting them to the potential problem of “doctor shopping.”
In addition, the system allows law enforcement/medical regulatory board/Medicaid fraud unit to request information. See chart 3. This will be for potential criminal activity regarding controlled prescription drugs if there is already an active investigation. This extremely limited type of access system has been very successful in thwarting controlled substances diversion and abuse in other states.
A study conducted in 2006 by Ronald Simeone and Lynn Holland Simeone Associates, Inc., regarding the ability for a PDMP to impact controlled prescription drugs concluded states that…. “monitor proactively have inhibited growth in prescription sales (for pain relievers and stimulants)…”
A May 2002 General Accounting Office (GAO) concluded that “State Monitoring Programs Provide Useful Tool to Reduce Diversion.” Its Concluding Observations were: Illegal diversion and abuse of prescription drugs and the associated criminal activity are growing problems in many states. Prescription drug monitoring programs offer states a more efficient means of detecting and deterring illegal diversion. These programs provide state health care licensing and regulatory agencies and law enforcement with quick access to comprehensive information on the prescribing, dispensing, and purchasing of controlled substances that are most likely to be targets for diversion. In addition, the report stated….”PDMPs have aided investigators and helped to reduce doctor shopping.”
7. What about children who are prescribed Schedule II drugs such as Ritalin? Will they be registered in the database?
Only patients 16 years and older will be included in the electronic database. This program will not highlight or stigmatize anyone who legitimately receives and uses medications prescribed by a doctor, but it will highlight potential illegal controlled substances diversion and abuse of controlled substances. Ritalin is the brand name of the Schedule II controlled substance methylphenidate. Methylphenidate is a central nervous system stimulant similar to amphetamine in the nature and duration of its effects. In medicine, Ritalin is used to treat Attention Deficit Disorder (ADD) and narcolepsy. In recent years, Ritalin has been increasingly diverted and abused by both youth and adults. Under Federal law, dealing in Ritalin is a felony.
8. Will the PDMP eliminate all the problems caused by the “pill mills” in Florida?
A PDMP is not a “silver bullet” that will eliminate entirely the problem with those involved in the illegal abuse and diversion of controlled substances. It is one “tool in the tool kit” that will be a major capability for Florida’s use in overcoming the problem with “pill mills.”
9. Will it be mandatory for physicians to access the database and check every patient’s prescription history?
No, health care practitioners are not required to access the database. It is only voluntary. However, it is a very helpful tool for a practitioner in providing better patient standard of care based upon the information in FAQ # 6.
10. Is there an established threshold for prescribing that can trigger a report to law enforcement authorities concerning a physician’s possible over prescribing?
Not at this time. The statute does not authorize this capability.
11. Who is responsible for the operation of Florida’s PDMP?
The Florida Department of Health.
12. How is the PDMP being funded?
The statute authorizing the PMDP specifically does not allow the use of state appropriations for establishing the PMDP. It did authorize the establishment of a non-profit organization, which was incorporated as The Florida PDMP Foundation, Inc., to conduct fund-raising for the program. In addition, federal grants and non-state grants have and will be applied for to fund the program.
The Florida PDMP Foundation, Inc is a non-profit 501 (c) 3 organization that independently raises funding for the establishment and operation of the Prescription Drug Monitoring Program (PMDP). It is authorized by Florida Statute 893.055.
The first year of set-up and operation then continuing operating requirements will require approximately $1,000,000. They will use that as their goal for fund-raising from donors of private monies.
13. What is a Patient Advisory Report and how is it used?
A Patient Advisory Report (PAR) is provided to a health care practitioner that has requested that if any patient is potentially “doctor shopping” that they wish to be notified. The database will have an alert capability that will then provide the practitioner the information. This helps practitioners identify those patients potentially engaged in the crime of "doctor shopping" (which is a felony in Florida). This allows the practitioner to intervene on their patient’s behalf and assist them in obtaining treatment, if they are addicted. See chart 2.
