Serious side effects

The DEA reclassified hydrocodone combination products in the fall.
The DEA reclassified hydrocodone combination products in the fall.

For long-term care operators, the reclassification of hydrocodone combination products to a more restrictive level isn't about the inconvenience of jumping through the latest bureaucratic hoop. It's about whether these new rules will make it more difficult for their residents and patients to continue getting the pain management they need.

Official policy since Oct. 6, the rule stems from a Drug Enforcement Administration initiative to reschedule hydrocodone combination products to Schedule II of the Controlled Substances Act. The DEA's rationale for the move is to combat prescription drug abuse. Hydrocodone combination products had previously been listed under the less restrictive Schedule III designation.

Tim Williams, director of pharmacy operations for Guardian Pharmacy, says he understands the intent of the rule and generally supports the move.

“This new rule came about from a lot of research and it has been made for a legitimate reason — hydrocodone is addictive and it slips out into the public,” he says. “The DEA felt it needed to act.”

Even so, the shift of hydrocodone combination products from Schedule III (C-3) to the more heavily controlled Schedule II (C-2) poses potential complications and delays for long-term care patients with chronic pain, especially as it relates to refills, pharmacy specialists say.

“Since a C-3 drug is allowed to be refilled five times — or six months from the date the original prescription — and C-2 drugs are only allowed full fills once or partial fills for up to 60 days, a written prescription from the provider will have to be obtained more frequently,” explains Rob T. Shulman, director of consulting services for Remedi SeniorCare. “This could result in a serious delay in obtaining the prescription, especially at night and on the weekends, when prescribers are commonly less accessible. The delay in obtaining the prescription will result in a delay of the patient receiving the medication.”

The main opioid pain medication affected by the change is Vicodin, a combination of hydrocodone and acetaminophen. The drug is commonly prescribed in the long-term care environment, Shulman says, so pharmacists are expecting to spend more time with Vicodin prescriptions.

“From an operational perspective, processing a C-2 takes an estimated 15% to 20% more time due primarily to an increase in recordkeeping compared to a C-3,” Shulman says. “This is both pharmacy technician time and pharmacist time during product review. This added labor cost would most likely be absorbed by pharmacy providers.”

Still, the new rule will also create an impetus for strengthening relationships among long-term care professionals, Williams says.

“It is also an opportunity for us to help the prescribers and facilities,” he says. “We need to collaborate with the DONs and physicians and come up with better processes to get medications to the residents who need them to control their pain.”

Associations concerned

As the new rule went through the input phase before becoming final in early October, the American Pharmacists Association and American Society of Consultant Pharmacists expressed concern about patients possibly being deprived vital medications.

“While the ASCP commends the DEA's efforts to combat prescription drug abuse, we believe that the increased controls imposed on these products will have an adverse effect in LTC settings,” association officials said in a prepared statement. “Because many residents of LTC facilities are patients living with chronic pain, it is imperative that they receive relief in a timely manner. It is likely that the increased controls will delay access to these crucial medications.”

Meanwhile, APA officials said they were anticipating confusion around refills of prescriptions written before the regulation took effect.

Technology factor

Because hydrocodone combination drugs are fast movers, pharmacies are increasingly relying on automation to dispense them, says Dawn Astorino, marketing communications manager at Parata. The regulatory change affects the way pharmacies will label and package these prescriptions, she says, as well as their security protocols, inventory, recordkeeping and reporting. 

“For many pharmacies, this means removing Schedule II drugs from automation and more time counting by hand,” Astorino explains.

Some companies, including Parata, offer secure dispenser kits to enable pharmacies to continue automating hydrocodone combination drugs, however. The kits contain tools to secure, track, audit and report on controlled substances.

The company's system has cells that automatically lock when they are closed and stay locked until they are removed from the unit. The cells are replenished while in the unit and open only when an authorized user verifies a barcode match between the cell and the stock bottle.

Device demand

Kirby Lester experienced “a significant increase” in demand for its KL1 and KL1Plus tablet counting devices immediately following the new rule's launch, says Mike Stotz, the company's senior marketing manager. In a one-month period, Kirby Lester experienced approximately a 45% increase in direct inbound inquiries via website and telephone, and a 30% increase in KL1 tablet counter devices either sold or shipped out for a free trial. 

“Our customers who might have been putting off any changes with their systems started going through the hydrocodone medications they produce and realized there has to be a better way than double-counting by hand,” Stotz says. “They need the right impetus for investing in automation and this is it. Now they see it as a tool to help their business rather than as an expense.”

New opportunities

While changing hydrocodone's status for combination drugs may cause some challenges for pharmacists and patients, Guardian's Williams prefers to see the situation as a new opportunity.

“I don't like to use the word ‘challenge,'” he says. “Anytime there is a change, there will be a period of time to look at processes. I don't see a challenge — I see reality. My job as pharmacist is to make sure my patients are being treated. If we have to get those meds, we need better communication with prescribing physicians. The regulation does provide an opportunity for physicians to evaluate patients' needs; whether that is changing from hydrocodone or not, that is something the physician could do.”

Williams sees the consultant pharmacist role becoming more important because the pharmacists are charged with evaluating patients monthly, and also with determining which therapies and treatment plans would best help patients manage their pain.

“Each individual is unique, with different needs,” he says. “Depending on the findings, they may see an opportunity to get a patient to try something else, such as tramadol or Tylenol with codeine.”

Shulman agrees tramadol could be a viable option.

“It is an opioid that is not covered by the new changes,” he says. “It is restricted, however, due to its abuse potential and is not considered a viable alternative when a written prescription cannot be obtained.”

Under the C-2 protocols, refills for hydrocodone combination products are being curtailed and physicians are charged with writing new prescriptions.

The full impact of the new rule may not be known until spring, Williams says, because six-month refills written before the start date are still being honored.

“We will know more when the refills expire in April,” he says. “Nevertheless, this is an opportunity for physicians to strengthen their relationships with patients.”

No going back

Despite the concerns associated with the new rule, Shulman says the reclassification is likely to be a permanent designation.

“The widespread heroin epidemic, coupled with an increased public awareness of drug abuse in general, means the outcry to restrict access to addictive prescription drugs will continue to escalate,” he says. “This could cause more pain medications to get reclassified. The Controlled Substance Act is not a document the DEA has traditionally changed with much frequency or without good reason. Therefore, I do not foresee this getting repealed or modified any time in the near future.”