New Pharmaceutical Monitoring Regulation Impacts Controlled Substance Dispensers
Last year, Mississippi lawmakers passed a bill altering the state's pharmaceutical monitoring program that state agencies began aggressively enforcing this year.
"The law has been changed to allow anyone dispensing controlled drugs to report to the Board of Pharmacy," said Vann Craig, executive director of the Mississippi State Board of Medical Licensure, of Senate Bill 2713 that Gov. Haley Barbour signed into law last May. "The change affects 'any entity.' A number of companies are trying to get physicians to dispense drugs in their offices. They must comply with this new law."
Mississippi's Prescription Drug Monitoring Program (PDMP) was originally established in 2005, when it was selected among 22 states to share $10 million in grant funding from the Congress-allocated Harold Rogers Prescription Drug Monitoring Program. The State Board of Pharmacy and Mississippi Controlled Substance Authority also contributed startup funds. Data collection began in May 2006.
Six million prescriptions are collected annually on a monthly basis from 800 controlled substances dispensers. Schedules II, III, IV and V are monitored electronically. Law enforcement and licensing boards—split equally—request 100 reports per month.
The 2008-enacted law "authorizes and directs the State Board of Pharmacy to implement a state-controlled substance monitoring program and impose penalties for the unauthorized use and disclosure of information maintained in such program in compliance with federal law."
It also spells out how failure to comply with the prescription monitoring program will lead to disciplinary action against a licensee and authorizes the Board to issue monetary penalties for noncompliance or intentional violation of the requirements.
As of November 2008, Mississippi was one of 38 states that had enacted legislation requiring PDMPs. Of those, 32 are operational and six remain in the start-up phase. Eleven states are taking steps toward legislation. Only Wisconsin and the District of Columbia have not taken steps to implement a program. Cost may be a factor in delaying implementation of a PDMP. The average startup expense is $350,000; state annual operating costs range from $100,000 to $1 million, depending on data college frequency, use of a third-party vendor, number of prescriptions written and filled, the number of schedules collected, and the use of required official forms.
Because Alabama, Louisiana and Tennessee have PDMPs, Mississippi is somewhat insulated from "doctor shopping" patients that often move their criminal activities to bordering states without a PDMP. A Model Interstate Compact, drafted by the National Alliance for Model State Drug Laws, facilitates states sharing prescription information across state lines. Other pilot programs are in the works across the country.
Program officials have insisted that monitoring program data has not been used to target subjects for an investigation, and that specific healthcare professionals will be reviewed after an official complaint is received.
The PDMP system highlights significant deviations concerning prescriptions, and states use the data to identify an existing problem and to determine the extent of the diversion or abuse. The system also notes patients who "doctor-shop" to obtain pharmaceutical controlled substances.
"It's not intended to red-flag" doctor-shoppers, said Craig, "but it will make it easier to track."
Safeguards are in place to protect patient confidentiality, said Craig, adding that only authorized individuals may access the controlled substance prescription information.
Because the size and cost of a national database has been deemed prohibitive, Congress has encouraged state-established PDMPs by providing funding through the Harold Rogers Prescription Drug Monitoring Program. A national PDMP would require data collection from nearly 700 million prescriptions from the nation's 65,000 DEA-registered pharmacies and respond to requests for data from more than 1.2 million DEA-registered practitioners.
"The new rule (for Mississippi) has been in place a few months," said Craig. "Now that doctors have had a chance to review it, we're getting cranked up."