Industry Update: Hydrocodone Combination Products

drugs and medicationsLet’s review for a moment the Controlled Substances Act of 1970 and the differences between the 5 categories, or schedules, of drugs.

The Comprehensive Drug Abuse Prevention and Control Act of 1970, otherwise known as the Controlled Substances Act (CSA), was created to combat and control drug abuse. This act classified drugs with potential for abuse as controlled substances and charged the Drug Enforcement Administration (DEA) with enforcement of such.

A controlled substance is defined as a drug with a risk factor for abuse and physical or psychological dependence. Here is a list of the schedules and a brief description of each:

Schedule I
Highest potential of abuse, no currently accepted medical use, and not legally dispensed in the United States

Schedule II
Drugs with a high possibility for abuse which can lead to severe psychological or physical dependence

Schedule III
Less potential for abuse and addiction than Schedule II

Schedule IV
Lower abuse potential than II and III with limited physical or psychological dependence

Schedule V
Lowest abuse potential

Often, upon recommendation from the manufacturer and the FDA, the DEA classifies new drugs into a schedule and will even reevaluate drugs that have been on the market for some time to determine whether they warrant any change in their classification. Such was the case with hydrocodone.

According to the FDAs official blog, “Hydrocodone is the most prescribed opioid in the United States, including 137 million prescriptions in 2013. While it is useful in the treatment of pain, it has also contributed significantly to the very serious problem of opioid misuse and abuse in the United States.”  Under a final rule issued by the DEA, hydrocodone combination products, such as Lorcet, Vicodin, and some cough suppressants, were placed in a more restrictive category of controlled substances, Schedule II, on October 6, 2014.

As a pharmacy technician, it will be important for you to stay abreast of any industry changes so you can relay that information to your customers and pass along their questions to the pharmacist.

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