Physicians Grapple With Schedule Change for Hydrocodone Combination Products

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Practice Management — January 2015

Tex Med. 2015;111(1):37-41. 

By Kara Nuzback

A go-to painkiller is now more difficult to prescribe to patients. On Oct. 6, hydrocodone combination products (HCPs) joined a class of drugs that includes cocaine, methadone, and oxycodone.

On that date, these common painkillers moved from Schedule III, which indicates a low-to-moderate potential for abuse, to Schedule II, which denotes a high potential for abuse. The rule change affects only hydrocodone combination products. Pure hydrocodone already was a Schedule II drug. 

Some physicians, such as Austin internist Liam Fry, MD, oppose the change on the grounds it will disrupt care for patients in severe or chronic pain. Other doctors, including Houston emergency medicine physician John Larkin, MD, say the change will curb prescription drug abuse and help combat fatal overdoses.

According to the U. S. Drug Enforcement Administration (DEA), a petition from a physician initiated the rescheduling of HCPs in 1999. DEA asked the U.S. Department of Health and Human Services (HHS) for an HCP scientific and medical evaluation and scheduling recommendation. 

In 2013, the U.S. Food and Drug Administration held a public Advisory Committee meeting, during which the committee voted 19-10 to recommend rescheduling HCPs from Schedule III to Schedule II. In December 2013, HHS passed the recommendation along to DEA. 

Two months later, in February 2014, DEA published its intent to move HCPs from Schedule III to Schedule II in the Federal Register and solicited public comments on the proposal. The agency says it received 600 responses to the change. 

"A small majority of the commenters supported the proposed change," DEA says. 

At TexMed 2014 in May, Texas physicians voiced their opposition to the reclassification in testimony before the Reference Committee on Science and Public Health. In its review of TMA's policy on hydrocodone, the Council on Science and Public Health also noted the complexity of the issue, agreeing on the need to study it further to develop a TMA position. In the end, TMA's House of Delegates reaffirmed TMA's policy, which states the association "supports the classification of hydrocodone as a Schedule III, not a Schedule II, drug." 

The Council on Science and Public Health's review of the policy regarding hydrocodone classification and management noted that while recognizing the public health problems caused by the misuse, abuse, and diversion of prescription narcotics that result in death and addiction, hydrocodone is associated with more drug abuse and diversion than any other opioid. TMA's opposition to reclassifying the drug hinges, in part, on members' perception that this would place unnecessary requirements on physicians and additional burdens on patients.

The council agrees that addressing the public health problems of misuse, abuse, and diversion of hydrocodone requires comprehensive and integrated strategies in education, monitoring, and enforcement.

TMA continues to oppose the change in classification and to support a focus on physician education.

The Impact on Physicians

Physicians can no longer delegate the prescription of HCPs to advanced practice nurses or physician assistants unless they are in a hospice setting or a hospital where the medical staff previously agreed to allow it.

The change also means physicians can't simply call a pharmacy to refill prescriptions for HCPs such as Vicodin or cough medicine. Instead, doctors have to write a new prescription every time, and the prescribed amount can cover no more than 90 days.

Physicians must write HCPs and all Schedule II prescriptions on official prescription pads from the Texas Department of Public Safety (DPS). You can order the pads online, or download, print, and mail the official order form

In November, DPS began allowing physicians and nonphysician practitioners with a valid controlled substances registration to pay online for their prescription pad orders. For detailed instructions, check out the Guide to Prescription Pad Ordering. If you need assistance, contact a DPS representative by calling (512) 424-7293. 

In lieu of waiting up to 30 days to receive the prescription pads in the mail from DPS, doctors can prescribe Schedule II products electronically, which helps reduce the chance of prescription fraud — a type of medical identity theft in which the perpetrator lifts a physician's credentials from a prescription pad and uses them to obtain drugs illegally. In fraud cases, when a pharmacist tries to confirm the paper prescription, the number provided on the forged document often connects him or her with the perpetrator, who poses as the physician and gives the pharmacist permission to fill the prescription. 

E-prescribing helps protect physicians from prescription fraud because the contents of the prescription cannot be altered during electronic transmission between the physician and the pharmacy. (See "How to Register for EPCS.")

A free e-prescribing application is available through the National ePrescribing Patient Safety Initiative

Obstacles for Patients in Pain

Many physicians who treat patients in chronic pain or those who've just had surgery are against DEA's decision to reclassify HCPs. Dr. Fry works in postacute care and treats many nursing home patients. She says in nursing homes, long-term care pharmacies process and deliver prescriptions, rather than retail chains like CVS and Walgreens.

"They usually make two or three deliveries a day," she said. But sometimes, even a few hours is too long to wait for a patient who is in chronic pain. And deliveries don't always arrive on schedule.

"In Austin, there's a lot of traffic," she said. In these cases, emergency kits are often a last resort to get patients the painkillers they need. Nursing homes may keep Schedule III, IV, and V drugs in a kit on site, maintained by the long-term care pharmacy, "with the idea that it was technically an extension of the pharmacy, with strict regulations over how the meds are dispensed and accounted for," Dr. Fry said.

Nurses may distribute the emergency drugs only after approval from a physician. Before the reclassification, the emergency kits contained HCPs for patients suffering intense pain. 

"We get people who just had surgery," Dr. Fry said. "They have major pain." Now, Dr. Fry says, "there are not a lot of options for that level of pain."

The emergency kits now contain only less effective painkillers such as tramadol and ibuprofen, which are not always safe for patients with kidney or gastrointestinal problems, or Tylenol with codeine, which is ineffective in 30 percent of the population, Dr. Fry says.

She says a possible solution to emergency situations is for a nurse from the long-term care facility to pick up a small HCP prescription from the nearest retail pharmacy to take back to the patient. The problem, Dr. Fry says, is the attending physician would have to fax the prescription to the pharmacy, and many pharmacists don't know they can legally fill Schedule II prescriptions faxed in for patients at long-term care facilities.

"They don't know about the nursing home rule because they don't get prescriptions from nursing homes," she said. The pharmacist on duty could choose not to fill the prescription.

"They're certainly not trying to be obstacles," she said. "But it's just one more thing to tack on when we're trying to give medicine to someone who's in pain."

Dr. Fry also says this plan would work only in nursing homes where physicians and nursing staff were in regular close contact. 

"It probably wouldn't work for all of them," she said. "There are still quite a lot of obstacles."

Putting a Dent in Drug Abuse

Dr. Larkin, who cares for patients at CHI St. Luke's Health System facilities in Houston, says he agrees with DEA's decision.

"From an ER perspective, I can't tell you how many codes I've run for patients who've overdosed and died," he said. "People overdose on accident, and it's so common." 

In some tragic cases, the patient is young, healthy, and using the drug recreationally. Younger adults and teens believe that because HCPs are prescription drugs, they are harmless, Dr. Larkin says.

He says having tried to resuscitate an overdose victim, then having to tell the patient's family he or she is dead because of an accidental overdose gives him a unique perspective on how readily available HCPs should be.

"I don't know if some of these clinical, office-based doctors have really gone through that experience," he said. 

Dr. Larkin says he also sees plenty of patients seeking HCPs either because they are hooked or because they want to sell the drugs on the black market.

Because chronic pain patients don't normally run out of medication, he says, "we're always skeptical and suspicious of people who tell us they need these medications."

"I've heard all sorts of stories, really pathetic excuses," he said. "It's really obvious that they're up to no good." 

Hydrocodone is well-known on the streets for being a recreational drug, and dealers can get $5 to $10 per pill, Dr. Larkin says.

He regularly searches the Prescription Access in Texas (PAT) database through the Texas Prescription Program, which the state legislature created in 1982 to track narcotic prescriptions. The law requires pharmacists to report Schedule II prescriptions to the monitoring program within seven days of filling the prescription. Using the program, physicians can search a patient's name to determine when he or she last received a refill for a narcotic prescription. 

With TMA's support, the legislature passed Senate Bill 1643 in 2013, which makes PAT easier to use and decreases hassles for physicians by allowing them to delegate information retrieval to nurses and connect to DPS through a health information exchange.

Dr. Larkin says if he searches a patient in PAT and finds a pharmacy refilled a patient's HCP recently, he turns down the request for more. 

"A lot of clinic doctors do not check those records. A lot of ER doctors don't do it," he said. For many physicians who've been practicing for 20 years or more, it's not in their normal routine, so they often bend to the patient's request and approve the refill, Dr. Larkin says. 

"They don't realize the damage they could be doing," he added.

Dr. Larkin says when he encounters patients with a pattern of abuse, he tries to gently confront them, but "they end up getting mad and walking out."

While opponents of the HCP schedule change say it reduces patient access to vital medications, Dr. Larkin says the limitations for Schedule II drugs are not unreasonable. If patients are using an addictive narcotic for pain, they should check in with their physician more regularly, he argues. (See "Top 3 Hydrocodone FAQs.")

In August, when DEA published the final rule moving HCPs from Schedule III to Schedule II in the Federal Register, DEA Administrator Michele Leonhart said, "Almost 7 million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents. Today's action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available."  

Kara Nuzback can be reached by phone at (800) 880-1300, ext. 1393, or (512) 370-1393; by fax at (512) 370-1629; or by email.


Top 3 Hydrocodone FAQs

Q: How should I refill a prescription for a hydrocodone product (HCP)?

A: You must write a new prescription.

Q: Do I have to see my patients face-to-face to give them a new prescription?

A: The reclassification offers no guidance on how often a physician needs to see a patient with an HCP prescription. Texas Medical Board (TMB) pain management rules say physicians should see patients with Schedule II prescriptions at "reasonable intervals," but TMB does not specify how often or whether a physician must see the patient in person. 

Q: How do I get official Schedule II prescription pads?

A: Order online, or print the official order form.

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How to Register for EPCS

Electronic prescription of controlled substances (EPCS) can lower a physician's risk of being a prescription fraud victim. To get started with EPCS:

  1. Make sure your e-prescription software is certified for EPCS, or shop for EPCS-certified software. DrFirst, a software solutions and services company, can connect you with vendors. Surescripts also offers a list of vendors.
  2. Your software vendor will have to verify your identity. E-prescribing vendors typically use a third-party authentication service that requires physicians to provide detailed personal information, including credit reports, to confirm the physician's identity. Only the third-party authentication service has access to the physician's private information, not the software vendor.
  3. Your vendor will ask you to create two identifiers to use whenever you prescribe a controlled substance electronically. Identifiers can take the form of a password, a fingerprint, a retinal scan, or a token. Hard tokens are pocket-sized electronic devices that generate a number when the physician pushes a button. The physician must then enter the number into an electronic prescription form within a short time frame, usually 30 seconds to a minute. Soft tokens work similarly but take the form of a smartphone app. 

Physicians who suspect prescription fraud should notify the Texas Department of Public Safety by calling (512) 424-7293 or emailing RSD_CES_Criminal[at]dps[dot]texas[dot]gov. For more information on EPCS, see "A Necessary Pain," July 2014 Texas Medicine, pages 55-59.

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May 13, 2016

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