Prescription Drug Monitoring Program

Update:

Last month I presented at the Prescription Drug Abuse Summit in Tampa (see attached article)
I also serve on the Program Implementation and Oversight Task Force and we prepare the launch of the Prescription Drug Monitoring Program on December 1st. We will have a Taskforce meeting in Tallahassee next week to discuss details of the pending launch.
Lots of work has to be done to educate doctors and to lower the resistance threshold. Unfortunately, we are facing push-back from the medical community regarding the prescription drug monitoring program. Those who resist its implementation raise privacy issues and (of course) consider it as "further government intrusion into the practice of medicine." I want to emphasize that this is NOT a Republican vs. Democrat issue but a PATIENT SAFETY and PUBLIC HEALTH issue!! We all should stand together in support of the program and work towards its successful implementation.
Attached you also find the rule which implements the Prescription Drug Monitoring Program.
Again, we need to convince doctors to use the program, otherwise we won't resolve the problem and many more Floridians will die!!
Yours
Bernd


August 27, 2010

Prescription drug abuse summit held in Tampa
By Nicole Hutcheson, St. Petersburg Times Staff Writer
At a summit in Tampa, medical professionals air concerns about a new state tracking program.

TAMPA - Come December, medical professionals will have a new tool to determine whether a patient is abusing prescription drugs.

But some worry that the Prescription Drug Monitoring Program, a new state system that tracks narcotic dispensing, will add a burden to their already heavy workload. Others question the privacy aspect of the new rules.

"Many physicians are very concerned about another regulatory issue," said Dr. David Weiland, vice president of medical affairs at Bayfront Medical Center in St. Petersburg. "To me, any regulation can be a barrier to real patients receiving adequate treatment for their pain."

The monitoring program was a hot topic at this year's Drug Abuse Summit hosted by Associates in Emergency Medical Education, a Lutz company that trains medical professionals. More than 140 people - including doctors, prosecutors, law enforcement officials and drug abuse counselors from across the country - attended the daylong event Friday at the Marriott Waterside in downtown Tampa.

"The goal is to come up with answers as a whole," said Sharon Kelley, executive director of Associates in Emergency Medical Education. "There is no one solution to this, you have to bring all the players together."

The drug monitoring program dominated many of the event's sessions, including how doctors should use the system and how to comply with federal privacy laws. The legislation, sponsored by Sen. Mike Fasano, R-New Port Richey, is meant to cut down on doctor shopping and overprescribed narcotics.

Here's how it would work: When doctors or pharmacist dispense pain pills, such as oxycodone, amphetamines and Xanax, they must report it to a centralized database. When the database goes online, pharmacists and doctors statewide will be able to search it to determine if their patients have received a similar prescription in the past. They have 15 days to report to the system, and failure to do so is a misdemeanor.

"A doctor will be able to look at the prescription history of their patient no matter which doctor they've been to," said Bruce Grant, director of the Governor's Office of Drug Control. "It's an added safety measure."

The statewide database is expected to cost about $12 million to get up and running by December. The Department of Health is implementing the system, but the law prohibits using state money for implementation. A combination of federal grants and private money raised by the Prescription Drug Monitoring Program Foundation is being used to fund the program. Funding is on track, Grant said.

More than 40 other states have such a system.

But there remained an air of hesitance among some at Friday's event. Their questions included: What would stop a patient from traveling across state lines to receive pain medicine? Would it violate any privacy laws? And how will law enforcement access the database?

Claude Shipley, project director for the state's Office of Drug Control, tried to quell concerns.

"There is this urban legend myth that you will be in violation of HIPAA (Health Insurance Portability and Accountability Act) using PDM (prescription drug monitoring)," Shipley said. "There is no civil liability. The statue is very clear on that."

Law enforcement would be able to get information from the system if it has an open investigation involving a doctor or patient.

Dr. Bernd Wollschlaeger, a family practitioner in North Miami, spoke in support of the monitoring program. He has been using an electronic prescription system for the past seven years.

On Friday, he told of a 47-year-old woman who needed help ending an oxycodone addiction.

Wollschlaeger started her on Suboxone, a medicine that helps patients with opiate withdrawal symptoms.

After researching his electronic prescription system, he learned that the woman was still receiving hydrocodone from her gynecologist. She had withheld that important information. After Wollschlaeger confronted the patient, they began a more honest discussion, he said.

"This served as a tool to start this dialogue. I didn't point the finger at the patient, but this gave me the tools I needed," he said. "(Prescription drug monitoring) will bring transparency, not policing."

Nicole Hutcheson can reached at nhutcheson@sptimes.com or (813)226-3405.

Prescription Drug Monitoring Program Issues

Comments:

Attached some of my concerns regarding the rules governing the Prescription Drug Program:

* "3) All dispensers will electronically report data to the Program's database not more than 15 days after the controlled substance has been dispensed.."
o Result: Organized drug purchasers and traffickers will go from clinic to clinic to buy drugs within the 15-days period and those clinics will delay reporting to the legal limit to allow their "clients" to purchase drugs because that's were the money comes from. These are the facts on the ground. How can we stop that? By lobbying for a reporting requirement within 24-hour time period. Every time I create an electronic prescription during a routine patient interaction in the exam room the prescription data is automatically being submitted to the e-prescribing database. E-prescribing software vendors (such as Allscripts) should upload all controlled substances directly to the monitoring program.
* "4) Data not accepted by the database system due to a substantial number of errors or omissions shall be corrected and resubmitted to the database by the reporting dispenser within five days of receiving written notice that the submitted data was unacceptable."
o Result: Crafty and clever dispensers may intentionally submit incorrect data, await the written notice and then resubmit the data after five days. Meanwhile, they can continue to serve the commercial drug dealers. Whats the penalty mechanism? How many times can they submit incorrect data without being fined?

Furthermore, one of my colleagues pointed out that the rules do not provide for fines, penalties, license suspension/revocation, or anything else for offenders, and especially for repeat offenders. The item above is limited to "failing to report", but does not cover purposeful misbehavior as described in my comments.
The way this is written,it allows dutiful physicians to look up and see if their patient is trying to scam them. It does NOT provide the department or law enforcement very easy tools to find and prosecute "pill mills", who are actually the real public health problem.

I am looking forward to your comments.
Yours

Bernd