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Prescription drugs

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Overdosing from prescription painkillers has emerged in recent years as a leading cause of deaths. More than 16,000 deaths — 43 percent of all fatal drug overdoses — were caused by abuse of painkillers such as OxyContin and Vicodin. It has grown to such an extent that several proposals — regulatory and legislative — have been put forth restricting access to the drugs taken by millions of Americans to relieve chronic pain.

A Food and Drug Administration advisory panel earlier this year recommended reclassifying some of the more widely used painkillers such as Vicodin and other hydrocodone medications to a more restrictive Schedule II classification.

Hydrocodone is the most prescribed drug in the country with more than 131 million prescriptions written for hydrocodone products in 2011. It is now classified by the FDA as a Schedule III drug, which has fewer controls. Under the proposal before the FDA, pharmaceutical companies would also be barred from marketing the medications for moderate pain, which would limit their use to severe pain for non-cancer patients.

The plan has drawn the support of the Drug Enforcement Agency, which last month urged the FDA to enact additional regulatory measures because of the rising rates of prescription drug abuse. Also, members of Congress have pressed the FDA to adopt the stricter requirements. Legislation has also been introduced to make it harder to obtain the painkillers.

Responding to the FDA proposal, the National Community Pharmacists Association has warned that the plan “would create significant hardships for all — leading to delayed access for vulnerable patients with legitimate chronic pain.” The impact of more restrictive controls will become better known from similar changes being implemented in New York.

The state is ahead of the FDA in many respects. Under the Internet System for Tracking Over-Prescribing Act enacted last year, hydrocodone is now a Schedule II drug in New York, ending automatic refills for the highly abused drug. The law also updates a prescription monitoring program to let doctors and pharmacists know on a “real time basis” if someone has been “doctor shopping” for multiple prescriptions and mandates electronic prescribing of controlled substances by December 2014.

Abusing prescription painkillers has reached epidemic levels. But there is also the other side of the issue that has to be considered with physicians fearing FDA restrictions could disrupt patient care.

There has to be a balance. Society, including the medical community, has to acknowledge and confront prescription drug abuse. However, regulators and lawmakers must consider the added burdens and costs imposed on millions of responsible Americans who depend on the medications used responsibly under the supervision of their physician to live productive lives.

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