Prescription Drug Monitoring Programs to Curb Controlled Substance Abuse

Soon after actor Heath Ledger died from a prescription drug overdose in January 2008, Marc Fleming, PhD, was watching an entertainment news show. A guest mentioned that Mr. Ledger may have still been alive if providers had paid better attention to a prescription drug monitoring database that tracks the use of controlled substances.

Dr. Fleming at the time was studying for his PhD at the University of Texas and working part-time as a pharmacist at a local Target. He already had nearly a decade’s experience as a pharmacist, and yet he had never heard of the programs. Neither had any of his colleagues and friends in the profession.

"I was like, databases—what is she talking about?” Dr. Fleming said in an interview with First Report Managed Care. “This database exists somewhere? Some states have this and we are not using it? I could not believe we were not using it.”

Today, Dr. Fleming is an assistant professor in the University of Houston’s division of Pharmacy Administration and Public Health whose research focuses on prescription drug monitoring programs, which have increased significantly in recent years. All states except for Missouri now have programs in place or have enacted legislation to operate them. They are usually intended for drugs the Drug Enforcement Administration refers to as schedule II, such as hydromorphone, methadone, oxycodone, fentanyl, and morphine; schedule III, such as lower doses of hydrocodone and codeine; and schedule IV, such as alprazolam, carisoprodol, and diazepam.

The designs of the programs vary, but typically when people go to outpatient or community pharmacies to obtain a controlled substance, information is entered into an online database. Pharmacists, physicians, nurse practitioners, and some law enforcement officials can access the data by logging into a password-protected Web site that includes all of the prescriptions a person has filled and when and where they filled them. If they notice a person has a history of getting prescriptions from multiple doctors or is filling the prescriptions too early, they can deny the prescriptions or tell him or her to come back at a later time.

The programs are in response to the increasing use and prescribing of opioids and other controlled substances. In 2009, outpatient retail pharmacies dispensed 234 million extended-release opioids and 22.9 million immediate-release opioids, up from 164.8 million and 9.3 million, respectively, in 2000, according to an analysis from SDI Health.

In 2012, 6.8 million people in the United States who were ≥12 years of age used psychotherapeutic prescription drugs for nonmedical use in the past month and 2.1 million abused prescription pain relievers, according to the National Institute on Drug Abuse. The most abused prescription drugs are opioids and benzodiazepines. The misuse and abuse of prescription opioids alone costs health insurers $72.5 billion per year in direct healthcare expenses, according to Dr. Fleming.

Nonmedical use refers to taking more of the drug than prescribed, taking a drug prescribed for another individual, or taking a drug illegally or without a valid prescription. Unlike with heroin, crack cocaine, and other illicit drugs, people who abuse prescription medications do not always have recognizable physical changes and often can function in work or social situations.

“It is not like they are strung out, their skin does not look a certain way, they are not itching,” Dr. Fleming said. “It is a slow progression. It is not like all of a sudden they are hooked.”

In August 2005, President George W. Bush signed into law the National All Schedules Prescription Electronic Reporting (NASPER) Act. Four years earlier, the American Society of Interventional Pain Physicians had proposed the legislation, and several organizations supported the idea. Still, the implementation and full funding of the law did not materialize, leaving it to the states to run their own programs.

A January 2013 report from the Congressional Research Service prepared for Congress noted startup costs for the programs range from $450,000 to more than $1.5 million and annual operating costs range from $125,000 to nearly $1 million. States receive much of their funding for their programs through fees from pharmacists, physicians, and health insurers.

NASPER last received funding of $2 million in fiscal year 2010, while the Harold Rogers Prescription Drug Monitoring Program offered states $7 million in grants in fiscal year 2012. Both federal programs are intended to provide states with funding for their prescription drug databases. Mr. Rogers, a Congressman from Kentucky, helped get the legislation enacted in 2002 after noticing an increase of controlled substance abuse in the state.

“He was very concerned about the devastation that the abuse of these drugs was [having] on many of his constituents,” Dave Hopkins, program manager for the KASPER (Kentucky All Schedule Prescription Electronic Reporting) system, said in an interview with First Report Managed Care. “He has taken it very seriously.”  

Since establishing its KASPER system in 1999, Kentucky has been at the forefront of innovations in prescription drug monitoring programs. KASPER began as a fax-based system before switching to an Internet-based system in 2005. Before implementing their programs, representatives from several states such as Ohio, Tennessee, Florida, and Montana visited Kentucky and met with Mr. Hopkins, who also travels throughout the state giving presentations and providing KASPER training sessions for prescribers.

In 2012, Kentucky passed legislation that mandated anyone who was authorized to prescribe or dispense controlled substances in the state must register and have an account with the KASPER system. Previously, KASPER was a voluntary program, in which prescribers could log into the system and request a report that showed all of the controlled substances the patient received that were dispensed in Kentucky. Prescribers are now required to use KASPER and review a patient’s record whenever they prescribe any controlled substance. In almost every program, states require prescribers to report any time they dispense a controlled substance, but Kentucky is among a few states to mandate that prescribers access the database before prescribing a controlled substance.

A limitation of the prescription drug monitoring programs is that patients can cross state lines to fill prescriptions. For instance, 7 states border Kentucky, so Mr. Hopkins and others noticed that people denied prescriptions would travel to those states because their information could not be accessed.

“Believe me, this is not just a Kentucky problem,” Mr. Hopkins said. “Every state that has a prescription monitoring program wants to be able to share data with other states. [To] the drug seekers [and] the drug dealers, the state borders do not concern them at all. They are going across state lines to get these drugs for abuse or for diversion.”

Kentucky is among 21 states that have joined the National Association of Boards of Pharmacy (NABP) InterConnect initiative that launched in July 2011 in response to requests from state prescription drug monitoring program administrators to share data across states. NABP pays for development and implementing the InterConnect program and also waives the participation fees for a minimum of 5 years. Through InterConnect, Kentucky is sharing data with Michigan, Indiana, Ohio, and South Carolina. By the end of 2014, the state hopes to share data with Illinois, West Virginia, Virginia, and Tennessee.

“People who are abusing [drugs] or if they are doing it for illegal means to sell it, they know the system,” Dr. Fleming said. “They are always 1 step ahead…[The NABP InterConnect] is really a big step towards this national program.”

So far, research on the effectiveness of the prescription drug monitoring programs has been limited. An analysis of 11 peer-reviewed research articles conducted between 2001 and 2011 found that the programs reduced doctor shopping, changed prescribing behavior, and reduced prescription drug abuse, according to a Congressional report.

Since the legislation passed in 2012, Kentucky has seen an increase in the number of registered users of the KASPER system, the number of reports the users are requesting, and the use of buprenorphine to treat opioid addiction. The University of Kentucky’s College of Pharmacy is currently conducting a 1-year study examining the effectiveness of the legislation. Researchers are also examining if the law has led to any unintended consequences such as of patients with legitimate pain are having trouble receiving medications.

“That is kind of where everybody is looking now—what are the results going to be from that?” Mr. Hopkins said. “[If the results are positive], I think several of the other states are going to be starting to consider maybe they want to do something similar to that type of legislation.”