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10/22/2014

DEA Reschedules Hydrocodone, Makes Changes to Controlled Substance Disposal

Kate Traynor

The Drug Enforcement Administration (DEA) in late August successfully concluded its 10-year campaign to move hydrocodone-containing combination products from Schedule III of the Controlled Substances Act to the more tightly regulated Schedule II.

DEA stated that the change affects several hundred brand-name and generic hydrocodone combination products, including cough suppressants, that are currently marketed in the United States.

According to DEA, the rescheduling serves to alert prescribers, pharmacists, and others to the potential for addiction and misuse of the combination products and underscores the need for careful monitoring and evaluation of the drugs' use.

The rescheduling, which ASHP supported, went into effect on October 6 in accordance with a final rule published in the August 22 Federal Register.

Prescriptions for hydrocodone combination products that were written before October 6 may include refills, but no such refills may be dispensed after April 8, 2015.

As with other Schedule II controlled substances, pharmacies must now use DEA form 222 to order hydrocodone combination products from a distributor, instead of using an invoice.

Written prescriptions are required for all Schedule II controlled substances. The Controlled Substances Act allows physicians to write multiple prescriptions constituting up to a 90-day supply of these medications.

The act also permits oral orders for an emergency supply of a Schedule II controlled substance, but a written prescription is required for any dispensing after the emergency period.

Because some states forbid practices that are permissible under federal law, healthcare providers should consult their state's regulations for the prescribing and dispensing of Schedule II controlled substances.

Congress in 1970 initially placed hydrocodone-containing combination products in Schedule III of the Controlled Substances Act. At that time, hydrocodone combination products containing opioid or nonnarcotic ingredients in quantities above a specific threshold were classified as Schedule II. But no such products are marketed in the United States, according to DEA.

DEA in 2004 had petitioned the Department of Health and Human Services to have all hydrocodone combination products moved to Schedule II—a change that may only be made with FDA's concurrence. FDA's response, issued four years later, was that Schedule III was the appropriate classification on the basis of the products' abuse potential and related factors.

DEA disagreed with FDA's analysis and in 2009 asked for a reevaluation. FDA took up the issue in earnest in 2013 after language related to the reevaluation was included in the Food and Drug Administration Safety and Innovation Act of 2012.

Advisers to FDA met in 2013 and voted in favor of the rescheduling, and FDA afterward indicated its support of the move.

DEA's proposed rule on the rescheduling was released this past February and elicited strong interest among pharmacists: According to the agency, 21% of the comments on the rule came from pharmacists or student pharmacists.

DEA stated that 60% of the comments from pharmacists and student pharmacists opposed the rescheduling, and those groups constituted 31% of all commenters who opposed the change. Overall, 52% of commenters supported the rescheduling in some way while 41% opposed it.

Commenters' reasons for opposing the rescheduling of hydrocodone-containing products included concerns about prescribing practices, patients' access to medications, effects on long-term care facilities, pharmacists' workloads, economic effects, and the belief that rescheduling will not prevent abuse or diversion.

Lisa Holle, assistant clinical professor of pharmacy practice at the University of Connecticut School of Pharmacy and health policy chair for the Hematology–Oncology Pharmacy Association, disagreed with the rescheduling decision.

Lisa Holle

"One of the potential consequences is having a higher amount of nonopioids being used for treatment of pain where opioids might be a good choice," Holle said. "We certainly hope that patients who need to be treated for pain aren't treated inappropriately or with incorrect pain medications."

She said that hydrocodone combination products are not widely used to treat patients at her practice site, the Carole and Ray Neag Comprehensive Cancer Center. But the products' previous placement in Schedule III made it possible for prescribers to easily phone in prescriptions for patients who urgently needed an opioid drug for pain relief.

Holle noted that the rescheduling affects hospital-based care in her state. In Connecticut, institutional medication orders for Schedule III, IV, or V controlled substances are good for up to 30 days, but orders for Schedule II narcotics must be renewed by a prescriber after a week.

ASHP's comments supporting the proposed rule stated that hydrocodone combination products are similar to Schedule II controlled substances and pose comparable public health risks but are easier to obtain under Schedule III.

The Centers for Disease Control and Prevention (CDC) in 2011 declared an epidemic of prescription drug abuse in the United States. According to CDC, drug overdosage is the leading cause of death in the United States, and opioid-related overdoses are largely responsible for those deaths.

Hydrocodone–acetaminophen combination products have been the most-prescribed medicines in the United States since at least 2006, according to data from IMS Health. The company reported that the use of these products peaked at 136.7 million dispensed prescriptions in 2011 and then declined to 136.4 million prescriptions in 2012 and 129.2 million last year.

Public health officials have expressed concerns about the existence of unused opioid drugs in patients' homes, where the medications may be abused by friends or family members. To address those concerns, DEA on September 8 released a final rule that allows pharmacies and certain other entities to establish collection sites where community members may drop off unused narcotics for safe disposal. That rule went into effect on October 9.

Firouzan Massoomi, pharmacy operations coordinator at the Nebraska Methodist Hospital in Omaha, has already updated his pharmacy's federal controlled substance registration certificate to become a collection site—a process that took less than five minutes to complete.

Fred Massoomi

"I think it is a big thing. And I think it's a step in the right direction," Massoomi said.

Collection sites should ensure that they follow all DEA requirements for handling and disposing of medications that they receive from the public.

"It's very important to understand that if you're going to do it, then you need to do it right," Massoomi said.

According to DEA, more than 2100 tons of narcotics and other prescription medications have been collected through national drug "take-back" programs the agency has supported since 2010. DEA intends for the new program to replace the national take-back initiative.

Entities other than pharmacies that may establish collection sites include drug manufacturers, distributors, reverse distributors, and narcotic treatment programs that have authority to handle Schedule II controlled substances. Community pharmacies and hospitals and clinics with onsite pharmacies may establish collection receptacles at long-term care facilities.

Registered collectors that have an onsite method for the destruction of controlled substances may establish mail-back programs, according to DEA.

Although DEA doesn't charge a fee to register as a disposal site, Massoomi speculated that there might be a hidden cost involved: DEA could be more inclined to audit registrants that operate disposal programs.

"This is something that I think pharmacy directors or registrants really need to weigh," Massoomi said.

Entities that don't establish collection programs are also affected by the rule because it creates new requirements for the way controlled substances are destroyed.

Among other things, DEA now requires that all controlled substances must be rendered "non-retrievable" during destruction. This means that the medication's physical or chemical state must be permanently altered so that the drug is no longer considered a controlled substance or analog.

Thus, the medications cannot be disposed of by flushing them down a toilet or sink or discarding them in a landfill, because these methods do not meet DEA's nonretrievability standard, according to the agency.

DEA declined to endorse specific disposal methods.

Massoomi said his hospital worked with the local DEA office before deciding on a commercial disposal system that appears to meet the agency's requirement.

He noted that effective October 9, hospital pharmacies no longer need to use DEA form 41 to document the wasting of partially administered doses of controlled substances.

Instead, DEA requires that such waste be properly recorded, stored, and destroyed in accordance with DEA regulations and applicable state and local laws and regulations.

According to DEA, form 41 must still be used "to record the destruction of controlled substances that remain in the closed system of distribution" and to document the destruction of controlled substances through a registrant's collection program.

A coalition consisting of the American Hospital Association and eight other groups released a letter dated October 6 asking DEA to delay the implementation of the disposal rule.

The letter stated concerns about requirements for the disposal of "small amounts" of controlled substances left over in syringes, i.v. solution containers, and medicated patches. According to the letter, the amount of leftover medication in these containers cannot be properly documented, so they cannot be processed for disposal by commercial waste management services.

The letter also raises health, safety, and regulatory concerns related to the disposal of used syringes that contain small amounts of unused controlled substances. Under a strict reading of the regulation, employees must manipulate and transport the used syringes for logging purposes instead of immediately placing them into a sharps container for disposal.

DEA, in an October 17 communication, stated that residual amounts of a controlled substance left in a syringe or vial after dispensing and administering to a patient are no longer in the practitioner's inventory and do not fall under the new disposal regulation. Additional information about the disposal regulation is available at www.ashp.org/DocLibrary/Advocacy/DEA-Proposed-Rule-on-the-Disposal-of-Controlled-Substances.pdf.