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Big Brother Monitors Scripts

 State: NY


I-STOP Ready to Launch amid Concerns by Doctors and Pharmacists


By Michael Whiteley, Eastern Bureau Chief


New York health officials are preparing on Tuesday to launch the nation's most ambitious prescription-monitoring program amid warnings from some pharmacists and doctors that the system isn't equipped to handle the flood of new drug data, much of it to be inputted by doctors signing up for the system for the first time.


Terence O'Leary, director of the New York Bureau of Narcotic Enforcement, said in an interview Thursday that the bureau actually launched the system on a limited basis on June 12.


Beginning on Tuesday, regulations adopted by the New York Department of Health require pharmacists to begin uploading data on controlled substances they dispense every 24 hours. The regulations also require doctors to check the prescription-monitoring  program before prescribing drugs on Schedules II, III and IV of the U.S. Drug Enforcement Administration's controlled substances list.


Also next week, New York pharmacists for the first time will be allowed to check the database before dispensing Schedule II, III and IV controlled substances to customers. The New York Legislature passed a law creating the new Internet System for Tracking Over-Prescribing in 2012.


New York law required controlled  substance reports from pharmacies beginning in 1973. The system opened to doctor access in February 2010.


The bureau has added servers and personnel to convert the state's existing  Prescription  Monitoring Program Registry, but is facing a backlog of applications from physicians,  physician  assistants and dentists seeking accounts through the Health Department's Health Commerce System.


"We've been doing outreach since back in 2012, and we are now flooded with applications because practitioners unfortunately waited until the last minute," O'Leary said.


He said the bureau has added 30 telephone lines to handle the doctors' applications. He said the number of queries from providers had reached 239,330 between June 12 and Thursday afternoon. He said queries have been increasing by between 17% and 24% a week throughout the summer.


He said 60,000 practitioners registered with the DEA to dispense drugs already have New York accounts. O'Leary said the agency also is warning pharmacies that they will have to wait until sometime next month to use "unattended reporting" software that will automatically upload pharmacy data every 24 hours without  a pharmacist needing to send the data into the bureau in the form of spreadsheets.


The regulations call for New York pharmacies to upload data for the first 26 days of August next Monday and to begin 24-hour reporting the following day.


He said the bureau has spent the summer cleaning up data files submitted by pharmacies that contain extraneous information, such as notations  that a patient has passed a bad check.


"We are confident that we can handle the increased burden we are experiencing on the prescription drug-monitoring program. We rolled it out ahead of schedule," O'Leary said.


But both the Pharmacists Society of the State of New York and the Medical Society of the State of New York are warning the system is not ready for launch.


"The bureau's website is cumbersome and is not very user friendly," said Selig Corman, consulting pharmacist for the Pharmacists Society. "I think there's going to be a real mess next week. I think their computers are going to be crashing. I don't think they're prepared for the volume."


Dr. Sam Unterricht, president of the Medical Society, said in a bulletin  to members on Aug. 16 that the group unsuccessfully asked regulators to change the new rules to allow doctors to check patients' drug records earlier than 24 hours prior to writing a prescription. He said the group warned New York Health Commissioner Dr. Nirav R. Shah on Aug. 6 that physicians are facing "enormous delays" in obtaining  the accounts they need to access I-STOP.


He said Shah has refused to postpone enforcement of penalties for failure to check the database. They are $2,000 for a first offense, $5,000 for a repeat offense and $10,000 if the violation results in "serious physician harm to any patient or patients."


Opponents of the program argue the fines are included in general Health Department statutes and should have been tailored to I-STOP.


"We also discussed changes in physicians' prescribing practices and the real possibilities of physicians retiring early from practice in light of the I-STOP law," Unterricht said in the bulletin. "While MSSNY (the Medical Society) supports the goal of controlling the drug epidemic, our continued opposition to the I-STOP law is well-known and documented in the halls of the New York State Capitol, and with Gov. Andrew Cuomo and Attorney General Eric Schneiderman.


"MSSNY will continue to recommend an enforcement  delay as well as necessary technical  changes to the law," Unterricht said.


The I-STOP  law, passed as Senate Bill 7637, was signed into law by Cuomo on Aug. 27, 2012. It required health officials to launch the program a year later.


The program is the second in the nation to require pharmacists to upload controlled  substance data in "real-time," which health officials determined should mean within 24 hours of filling a prescription.


Oklahoma, which also requires real-time uploads, has interpreted the state law to require pharmacies to upload data to the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control within five minutes of dispensing the drugs to a customer.


The bill also makes New York one of a minority of states that require doctors to check the database. Lawmakers in Florida rejected a similar  proposal last session in the face of staunch opposition from the Florida Medical Association.


Massachusetts, Kentucky  and Tennessee also passed laws in 2012 requiring that doctors consult their databases, although  the states differ on which drugs trigger the requirement.


I-STOP also requires doctors to use electronic prescriptions for all controlled substances beginning on March 27, 2015.


Cuomo said the legislation sets a new standard for the nation's prescription drug-monitoring programs by requiring real-time data entry, e-prescribing and database checks by doctors.


O'Leary said health officials settled on 24 hours as the measure of real-time  based on the conclusion of a study of prescription-monitoring programs by the University of Kentucky.  He said the state was positioned to set the standard for PDMPs because it already requires doctors to use tamper-proof prescription pads.


On Wednesday, the New York State Health Department posted a listing of comments to the new I-STOP  regulations,  which  were adopted as an amendment to Part 80 of Title 10 of the New York Code of Rules and Regulations, effective next Tuesday.


The department said many practitioners, pharmacists and professional organizations supported the regulations. The Health Department made no changes to the new rules, which were published June 19.


Commenters said:


• A requirement that pharmacists report "zero controlled substances" on days they are closed or dispense no controlled substances should be delayed for six months to allow software vendors to modify reporting applications. The regulations require pharmacies to file zero controlled  substance reports within 14 days. The Department of Health said the zero reports use the same software required for daily reporting.

• Pharmacies should be allowed to report within "one business day" instead of every 24 hours to accommodate pharmacies that close on the weekends. O'Leary said the reports can be completed within five minutes at the close of business each day.

• Out-of-state pharmacies should be allowed to check the database to prevent doctor-shopping in neighboring states. O'Leary  said the bureau is in the process of developing  a system for out-of- state checks as the next phase in the conversion to I-STOP.

• Doctors and other prescribers who work at hospitals should be able to use hospital administrative staff to check I-STOP. The Health Department said the new rules will allow hospitals to designate staff members to check the database.

• Doctors should be able to check the database 36 hours before a prescription is issued. The

Department of Health said the 24 hours given doctors by the regulation allows doctors to check a patient's record outside of working hours, while ensuring the data is timely.


George Rontiris, the co-owner of Titan Pharmacy in Queens N.Y., which focuses on workers' compensation claims in Queens, said Thursday he's reserving judgment on I-STOP until the system goes into full operation next week.


He said a key will be the ease with which  pharmacies can check the database to ensure that doctors are following the law.


"I think having to report every day is a little excessive, but we're going to be checking the database," Rontiris said. "You never know whether a doctor's office is going to do the checks."


The regulation, which was adopted as proposed, is here.


SB 7637 is here.


Comments on the regulations and responses are here.

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