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New Changes in Regulations for Certain Prescription Painkillers

Han FengHave you heard about recent changes related to the regulation of certain prescription painkillers? Based on reports of dependence, abuse, and deaths, the Drug Enforcement Administration (DEA), a U.S. federal law enforcement agency, decided to classify tramadol as a controlled substance and increase regulation of hydrocodone combination products, such as Hycodan, Lorcet, Tussionex, and Vicodin.

What is a controlled substance?

Controlled substances are drugs that have potential for abuse or dependence and are regulated by the federal government. The DEA relies on a drug “schedule” to classify and restrict use of certain medications and substances. Schedules range from I to V.

Schedule I is the category for drugs and substances with no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse. For drugs and substances approved for medical uses, Schedule II is the most restrictive category with the highest potential for abuse or dependency. Schedule III - V medications have lower potential for abuse and risk of dependency.

Are there any risks to taking aspirin?

Aspirin can increase the risk of bleeding in the stomach, small intestine, and brain. Normally, there is a layer that protects the insides of the stomach and intestine from the acid in your stomach. If aspirin is taken at high doses and for a long time, it can slowly damage this layer. This damage can lead to bleeding. Using aspirin to prevent blood clots can also affect the natural healing of damaged blood vessels and increase the risk of bleeding in the brain.

What can I expect when I go to fill a prescription for tramadol?

With the new changes, prescriptions for tramadol may be refilled up to five times in six months after the date on the prescription. Prescriptions can still be called in, faxed, or sent electronically to the pharmacy by your doctor’s office as long as the office follows the DEA rules on sending prescriptions by these methods. Prescriptions may be transferred from one drug store to another, but can only be transferred once. There may be additional requirements based upon your state’s laws. Ask your pharmacist for how the new DEA ruling might affect your tramadol prescription.

What can I expect when I go to fill a prescription for hydrocodone combination products?

Refills of hydrocodone combination products will require a new prescription for each refill. Many states do not allow hydrocodone combination product prescriptions to be called in, faxed, or sent electronically to the pharmacy. If you have questions about filling a prescription for hydrocodone combination products, contact your pharmacist.

What if I still have refills left on my previously written prescription?

The DEA requires that all tramadol prescriptions must be filled according to the new regulations beginning August 18, 2014. Prescriptions written prior to August 18 must also follow DEA’s new restrictions. If your current prescription was written more than six months ago or was refilled more than five times, a new prescription will be required. Additional state-specific regulations may affect how you can refill your prescription for tramadol. New regulations for dispensing hydrocodone combination products will take effect October 6, 2014. Prescriptions written prior to October 6 and those that have refills may continue to be filled as written on the original prescription or until April 8, 2015—whichever happens first. If your current prescription is more than six months old or has been refilled more than five times, a new prescription will be needed. Additional regulations in your state may affect your prescription for hydrocodone combination medications.

By Han Feng, Pharm.D., PGY2 medication safety resident, Johns Hopkins Hospital, Baltimore