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Generics pose new threat in addiction fight

Published on NewsOK Modified: December 16, 2012 at 10:41 am •  Published: December 16, 2012

LOUISVILLE, Ky. (AP) — Kentucky's struggle to curtail prescription-pill abuse will suffer a setback if a wave of generic versions of painkillers reaches the market without safeguards that make them harder to crush for a quick high, political and law-enforcement leaders said.

Patents for OxyContin and Opana ER — opioid pain relievers used to treat moderate to severe pain — are set to expire next year, paving the way for generic versions of those powerful medications to reach pharmacies. Those brand-name drugs were popular sources with abusers until tamper-resistant formulations were added that made them harder to crush — a practice used by abusers to inject or snort the drugs.

Opioids are drugs that simulate the effects of natural narcotics, such as the opium poppy. They are typically prescribed for people already taking pain medications, including cancer patients, to treat severe pain flare-ups.

The fear now is that cheaper generic versions of those often-prescribed painkillers won't feature some form of abuse deterrence. Without that, they could become the new drugs of choice for abusers in a state where more people die from drug overdoses than car wrecks.

"We are running perilously close to another potential pain pill cliff," U.S. Rep. Harold "Hal" Rogers wrote in a recent opinion piece.

There are limited versions of generic painkillers on the market now and more generics are expected to be introduced in the coming year. Most of the generic painkillers don't have such safeguards. The concern among Kentucky officials is that sales of the cheaper generic versions lacking the anti-abuse features will overtake the brand name drugs with the safeguards.

Rogers and his fellow Kentucky Republican, Senate Minority Leader Mitch McConnell, are pressing the Food and Drug Administration to prevent "crushable" forms of those generic painkillers from pouring into Kentucky next year.

Rogers, whose Appalachian district has been plagued by prescription abuse, said introduction of easily crushable generics would be "downright disastrous," jeopardizing painstaking gains made in the fight against abuse of drugs found in family medicine cabinets.

"We know the storm's coming," said Clay County Sheriff Kevin Johnson. "We're sitting here trying to prepare for the hurricane."

Prescription-pill abuse remains rampant in his eastern Kentucky county, he said. The craving for pills fuels crimes — people breaking into homes to rummage through medicine cabinets and steal electronics to generate cash to obtain painkillers, the sheriff said.

"Our biggest problem here is without a doubt the controlling of prescription drugs, plain and simple," he said.

The Generic Pharmaceutical Association, an industry trade group, defends its role as a supplier of "lifesaving, affordable" medicines.

"Generic manufacturers comply fully with all FDA requirements and are committed to working with the agency to ensure the safety and quality of the medicines they make," the group said in a statement.

Kentucky lawmakers took aim at prescription-abuse woes by passing legislation this year that bolstered the state's prescription monitoring system and focused on pain management clinics. The law requires all new pain management clinics to be owned by licensed medical providers and to have medical directors in charge. It also requires all doctors, dentists, optometrists, registered nurses and podiatrists who write prescriptions to use the state's prescription monitoring system, known as KASPER.

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