Legislators aim to curb abuse of pharmaceuticals

In this Jan. 28, 2014 photo, pharmacist Leroy Stahlman counts capsules as he prepares to fill a prescription at Tolson's Drugs in downtown Jefferson City. Proposed legislation would require monitoring of prescribing and dispensing of controlled substances.
In this Jan. 28, 2014 photo, pharmacist Leroy Stahlman counts capsules as he prepares to fill a prescription at Tolson's Drugs in downtown Jefferson City. Proposed legislation would require monitoring of prescribing and dispensing of controlled substances.

In 2012, Sen. Rob Schaaf, R-St. Joseph, vowed to stand on the floor until his legs gave out in opposition of a Missouri bill that would establish a statewide program created to track prescribed controlled substances.

Three years later, Schaaf spent Wednesday morning on the Senate floor debating a measure that would create such a program in Missouri.

However, this time around, he was its sponsor.

Schaaf introduced Senate Bill 111, which was combined with Senate Bill 63 to form a committee substitute March 11. After much debate, Schaaf requested the substitute be put back on the informal calendar Wednesday for perfection, meaning it could be called back to the floor soon.

A public hearing for House Bill 816, which would also establish a prescription drug-monitoring program, took place Wednesday by the House Health Insurance Committee.

A total of 49 states have implemented prescription drug-monitoring programs. These programs established state-operated electronic databases that store information relating to the prescribing and dispensing of these medications.

Missouri is the only state that has not implemented a program - even Guam, an unincorporated U.S. territory, has a database.

However, the Show-Me State could join the rest of the country this session, as legislators in both chambers have proposed measures to establish a prescription drug-monitoring program.

"We have to have some computerized system to be able to collect the data to stop this terrible prescription abuse," said state Sen. David Sater, R-Cassville, sponsor of the bill combined with Schaaf's.

An "epidemic' of prescription abuse

If all the painkillers prescribed in the U.S. in 2010 were distributed evenly among every adult in the country, each would receive a one-month supply of the drugs, according to the Centers for Disease Control and Prevention (CDC).

Prescription medication use has skyrocketed in the past few decades, and along with this surge there has been a parallel increase in the abuse of pharmaceuticals, which the center has dubbed an "epidemic" in the country. According to the CDC:

• The amount of prescription painkillers sold in the U.S. has increased by 300 percent since 1999.

• In that time, the country's drug overdose death rate has more than doubled.

• Prescription drugs were involved in more than half of all overdose deaths in 2013; annually, nearly 15,000 Americans die from an overdose of prescription painkillers.

Alicia Ozenberger, deputy director of ACT Missouri, a not-for-profit organization aimed at reducing substance abuse, said our culture, including popular media, has led to a normalized view of these medications, which has led to increased abuse.

"A lot of kids think if a doctor wrote a script for it, then it's not that bad," Ozenberger said.

How the programs work

In states and territories that have implemented a drug-monitoring program, medical professionals who prescribe or dispense controlled substances are assigned a username and password to log into a network where they can input and view records of all prescribed schedule II through schedule IV controlled substances. These are defined as drugs with proven medical benefits that have the possibility of abuse, according to the Title 21 United States Code Controlled Substances Act.

Forty-five of the states or territories with a program allow for interstate exchange of information in some manner as of December 2013, according to a report from Congressional Research Service. One form of interstate communication is the Prescription Drug Monitoring Information Exchange Architecture, which creates "hubs" that data are sent through at the state and national level and allows for "hub-to-hub" exchanges.

Before a physician prescribes a controlled substance, the doctor logs into the database and checks to see the patient's prescription history. This process happens on the dispensing side as well, as a pharmacist is given access to the database. Using their professional judgment, the prescriber and the dispenser decide whether to write or fill the prescription.

Organization of these programs varies among states, especially in regards to who can access the database and which agency houses the program, according to a report by the Congressional Research Service. The report found monitoring programs have helped identify and prevent drug abuse as well as enable treatment. Prescription drug-monitoring programs also allow collection of data that outline drug abuse trends for public health initiatives.

One of the biggest challenges the programs aim to stop are "doctor shoppers," said Rep. Holly Rehder, R-Sikeston, sponsor of House Bill 130. These are patients receiving controlled substances from multiple practitioners, where the individual doctors are unaware of the repeat prescriptions, according to the CDC.

The costs of these programs vary greatly among states, according to the Congressional Research Service report. Start-up costs range from $450,000 to $1.5 million, and annual operating costs range from $125,000 to $1 million. States fund the programs in different ways, including donations, general revenue and grants.

Two federal grant programs provide some funding: the Harold Rogers Prescription Drug Monitoring Program grant, handled by the U.S. Department of Justice, and the National All Schedule Prescription Electronic Reporting Act of 2005 grant, managed by the Department of Health and Senior Services.

Missouri's proposed measures

House Bill 130 and Senate Bill 63 are similar, as Rehder and Sater worked together during the drafting process, Sater said. Schaaf's proposed legislation differs in security measures of the database and enforcement of the programs.

Rehder's and Sater's measures would allow for Missouri's data to be shared with other states in the national database.

"Why not use something that's been working for a while?" Sater asked.

Rep. Kevin Engler, R-Farmington, proposed House Bill 816, which also would allow for interstate sharing of the data, but would demand the measure be taken to a vote of the people, he said.

Schaaf, a family physician, said there are 30,000 pharmaceutical prescribers and dispensers in Missouri alone, which he believes is too many people who would have access to the database. He is also wary of the loose enforcement regulations placed on prescribers and dispensers.

"In the other states, which Rehder's and Sater's bills emulate, many of them don't require (prescribers and dispensers) to look at the database," Schaaf said. "I've taken that and made that a moot point because prescribers and dispensers aren't even given access to the database."

His solution is to create a unique program in Missouri housed in the Department of Health and Senior Services' Bureau of Narcotics and Dangerous Drugs. Only the department would have access to the database. Prescribers and dispensers would electronically submit prescription information to the department but would not be allowed to access the database, Schaaf said. The senator also said prescribers and dispensers in Missouri could access the national database simply by obtaining a username and password.

"This (program) is a severe infringement on our liberty," Schaaf said. "So, if we're going to do it ... let's at least protect our citizens by not giving access to 30,000 people."

Engler said he is indifferent as to where the program should be housed; he just wants a database to be established. He said the program's benefits outweigh the small chance of a breach in security.

"People are dying in the state right now," Engler said. "That is a reality, not a possibility."

Sater, who is a pharmacist, said he didn't like the idea of housing the program in the department.

"I don't want another piece of government bureaucracy running the program," Sater said. "The government doesn't do very good in running programs."

ACT Missouri believes the best practice for the program and Missouri's residents would be to join the national database, Ozenberger said.

"It's a hoop to jump through," she said. "If we were tied to the national database, then you would only have to have one username and password."

Schaaf called the committee substitute a "very good compromise."

"I'm just glad to see that the two senators have come to compromise," said Sen. Doug Libla, R-Poplar Bluff, who is chairman of the committee.

Libla said there is "still work to be done" on the fiscal notes of the measures.

The committee substitute is expected to cost $966,000 for fiscal year 2016. Costs are expected to increase in the next two years, at $5.8 million and $6.5 million for fiscal year 2017 and 2018, respectively. Sater said his biggest concern with the bill is the cost. Engler's measure requires all funding for the program must be from gifts, grants and donations.

All four bills include varying penalties to ensure those with access to the database do not disclose the information. Both House bills would set this at a Class A misdemeanor, while the Senate Committee Substitute would set this penalty at a Class D felony.

The measures also set different penalties for a dispenser who purposely doesn't submit the information or intentionally puts incorrect information into the database. Both House bills set this at a $1,000 fine for each violation, while the Senate Committee Substitute would charge the individual with a Class A misdemeanor.

If a patient's information is disclosed, the Senate Committee Substitute would reward the individual $25,000 in damages, as well as compensatory damages, attorney fees and court costs.

At the federal level, multiple bills have been proposed this session to establish grants to help states fund the programs. Many of these measures stipulate a state must allow for interstate sharing of information to be eligible for the grants.

Engler said if the national measures passed and Missouri's program ended up being ineligible for these federal grants, there are plenty of other sources for funding, including agencies that want the program established.

Fixing the problem

Schaaf said neither version of the legislation will fix the largest factor in prescription drug abuse. According to Schaaf, the biggest problem is not those engaged in doctor shopping, but those who lie about pain in order to obtain a single monthly prescription and sell it for profit rather than consuming it, he said. No form of a monitoring program could catch this type of patient, and he is unaware of a method that would be successful, Schaaf said.

"This is why these programs will never be effective at stopping overdose deaths," he said. "It's because they don't catch the liars."

Ozenberger said she considers the senator's argument "invalid."

"Everything we do, we chip away at the problem," she said. "We know when it's harder for kids to access the drugs, it's harder for them to use them and abuse them."

Another potentially-problematic aspect of the program is that with reducing prescription drug abuse, there has been an uptick in the use of non-prescription drugs, especially other opiates such as heroin, according to the Congressional Research Service. This is caused by the high cost of prescription medications and the reduction in the number of these substances available due to the success of monitoring programs.

"That is something we can't control," Rehder said. "I've had (drug addiction) explained to me like it's a balloon, where you're squeezing it on one end and it's just getting bigger on the other end."

Sater said all legislators can do is focus on one problem at a time.

"We definitely have a problem with narcotic prescription drugs," he said. "So let's treat the symptoms of this problem first."

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