How to Prepare Your Pharmacy for Dispensing Hydrocodone Products

Hydrocodone and Hydrocodone combination products are the United States’ most commonly prescribed pain relievers. In an effort to mitigate the risk of their misuse, the Drug Enforcement Agency (DEA) is moving forward with a ruling which will reclassify Vicodin, Lortab, Norco and generic hydrocodone combination products from their current Schedule III status to a Schedule II.

While Hydrocodone itself has always been Schedule II, by combining it with other over the counter drugs like acetaminophen and ibuprofen, they were able to fall under Schedule III and avoid the complication of Schedule II. Now that’s changed.

Schedule II imposes additional rules regarding the storage and dispensing of Hydrocodone and Hydrocodone combination products, and your pharmacy must be prepared to adhere to these new procedures.

What is Schedule II?

Medications that are designated as Schedule II carry potential for misuse as they come with a higher likelihood of psychological addiction and physical dependence. As such, the DEA has determined this class of medication requires additional monitoring by a physician and comes with more restrictions for prescribing and dispensing.

How will this affect my pharmacy?

For starters, physicians are no longer permitted to call or fax in the prescription to a pharmacy and refills are not allowed. Patients are now required to have an office visit before the medication can be prescribed (read: new script every time).

Pharmacies who choose to continue carrying the drug will be required to keep the medications locked in the pharmacy safe any time the drug is not being dispensed. The DEA will also require heavier tracking processes to document every unit that comes in and out of the pharmacy. The corresponding paperwork will need to be submitted to the DEA at regular intervals.

All Hydrocodone products dispensed after the deadline must have been brought in under Schedule II processes; therefore, all pharmacies must sell or destroy their current stock of drugs by the deadline.

When does the ruling go into effect?

Pharmacies have until October 6, 2014 until the ruling goes into effect.

There is currently no additional guidance for pharmacies on how they should handle remaining refills for hydrocodone combination products that were prescribed prior to the change.

Stricter regulations on obtaining and dispensing hydrocodone combination products don’t have to be a headache. By preparing your pharmacy accordingly you will help with the DEA’s efforts to deter the abuse and misuse of these medications.

Additional Ways to Prepare:

1. Limit inventory immediately
2. Educate staff on changes being made
3. Educate patients/consumers
4. Call/fax a letter to physicians and notify them that you are aware of and ready for such changes
5. Consider non-narcotic compounded medications as an alternative to pain therapy.

For more information please visit the Federal Registrar at: https://www.federalregister.gov/articles/2014/08/22/2014-19922/schedules-of-controlled-substances-rescheduling-of-hydrocodone-combination-products-from-schedule or contact our compounding advisor by calling 800-878-2822. We’re always here to help!