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Congress Seeks Answers to Growing Rx Drug Abuse

By Mari Serebrov
Washington Editor

WASHINGTON – With the misuse and abuse of drugs becoming the leading cause of accidental death in the U.S., Congress is looking for ways to curb the use of some prescription painkillers and insomnia/anxiety drugs.

One suggestion is to limit the indication for certain opioid drugs. Under the Stop Oxy Abuse Act, H.R. 1316, drugs containing controlled-release oxycodone hydrochloride could no longer be approved to treat moderate to severe pain; their approvals would be restricted to severe pain only.

Such "powerful and seductive narcotic prescription drugs" shouldn't be used to treat a tooth ache or a sore knee, Rep. Mary Bono Mack (R-Calif.), sponsor of the bill, said as she opened a House subcommittee hearing last week on drug diversion.

Bono Mack, the sponsor of H.R. 1316, also is pushing for more education for providers. Another bill she's sponsoring, H.R. 2119, would require physicians to get special certification before they could prescribe controlled substances.

Testifying before the House Subcommittee on Commerce, Manufacturing and Trade, Richard Kerlikowske, director of the Office of National Drug Control Policy, agreed that education, both of physicians and the general public, is key to confronting the problem. He noted that the death toll from overdoses of prescription drugs, which many people assume are safer than illegal drugs, is double that of the death toll from heroin, cocaine and other illegal drugs combined.

Kerlikowske applauded the Obama administration's four-pillared plan to fight the increase in prescription drug diversion. The first pillar calls for drugmakers to develop educational materials for prescribers on the safe use and storage of specific drugs.

The other pillars involve monitoring of certain drugs, safe disposal mechanisms for unused and expired drugs, and law enforcement efforts.

All but two states have some monitoring system on the books, thanks to a federal grant program that funds the state databases. A monitoring program can help prevent "doctor shopping" to satisfy a prescription drug addiction and identify inappropriate prescribing patterns that could signal a "pain clinic" or "pill mill," in which doctors indiscriminately write prescriptions regardless of a "patient's" need for a drug. In the case of pill mills, the prescriptions are filled on the premises.

Pill mills are spreading throughout the U.S., Joseph Rannazzisi, deputy assistant administrator of the Drug Enforcement Administration, told the subcommittee. in many cases, the pain clinics and pill mills operate just inside the law.

Part of the problem is that the drug monitoring programs vary widely among the states, and their effectiveness is limited across state lines because of a lack of interoperability.

As for disposal programs, Kendra Martello, assistant general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), noted that Congress gave the DEA new authority in 2010 to establish secure disposal programs. Although the DEA held a public meeting in January 2011, it has yet to propose regulations to implement an ongoing prescription drug disposal program.

If the DEA would fully implement its new authorities, it could reinforce the "closed system" that's in place to help prevent the diversion of prescription drugs that are also controlled substances, Martello said.

Rannazzisi, in turn, appealed to everyone in the prescription drug supply chain to police each other. There are obvious red flags, he said, that should trigger concern across the supply chain.

Bono Mack echoed that sentiment, reminding everyone from the drugmaker to the prescriber that they have a responsibility to find solutions to what has become a national epidemic.

While the subcommittee hearing focused on curbing the abuse and misuse of prescription drugs, some of the testimony expanded the discussion to supply chain diversion and counterfeit drugs. In her testimony, Martello outlined several measures PhRMA is supporting to strengthen the domestic prescription drug supply chain:

increased licensure requirements for wholesale distributors;

continued exercise of the DEA's authority over online sales of prescription drugs that are controlled substances;

increased oversight of drug repackagers;

more funding for the DEA's Office of Diversion Control;

tougher criminal penalties for counterfeit drugs.

The SAFE DOSES Act, S. 1002, would stiffen the penalties for trafficking in stolen drugs and increase the penalties for altering or falsifying the labeling or documentation of a stolen or expired drug. The Senate Judiciary Committee last week delayed markup of the bipartisan bill until Thursday. (See BioWorld Today, Feb. 27, 2012.)

Generics Not Always the Answer

The conventional wisdom that generic drugs and therapeutic substitutes are the best economic deal for the health care system doesn't always hold true, according to a new Government Accountability Office (GAO) report.

While generics saved the U.S. health care system more than $1 trillion from 1999 to 2010 and they could save even more if there were 100 percent utilization instead of the current 78 percent, those numbers may not tell the whole story.

In reviewing research on the cost-savings of generics, the GAO found that most studies simply compared the prices of generic drugs to brand drugs. But the studies that compared the total health care costs involved showed the cheaper drugs actually increased costs in some cases.

For example, one study found that patients on selective serotonin reuptake inhibitors (SSRIs) who switched to cheaper therapeutic substitutes mid-treatment averaged $881 more in total health care costs than those who stayed on the more expensive brand SSRI due to a higher rate of hospitalizations and emergency room visits.

Generic substitution also may prove more costly for brand drugs with a narrow therapeutic index (NTI). The GAO cited a study that looked at the annual health care costs for kidney transplant patients treated with NTI immunosuppressants. Those who began their treatment with a generic drug averaged expenses of $36,482 compared with $32,171 for the patients prescribed the brand drug from the start. Researchers found that patients on the generic needed higher doses of the drug or an additional immunosuppressant to maintain their new kidneys.

CMS Plans Monthly Drug Pricing Survey

The Centers for Medicare & Medicaid Services (CMS) is starting the process of developing a National Average Drug Acquisition Cost (NADAC). A new pricing benchmark based on the national average costs pharmacies pay for Medicaid-covered outpatient drugs, NADAC is intended to give states a more accurate reference price as a base for their drug reimbursements. The acquisition costs will be collected directly from pharmacies through a voluntary nationwide survey to be conducted monthly, according to a CMS information collection notice.