“It was an anomaly that hydrocodone was scheduled differently than other potent opioids,” said Michael Von Korff, vice president of the advocacy group Physicians for Responsible Opioid Prescribing. The move closes the “Vicodin loophole,” which allowed patients to obtain up to six months of pills with one prescription and easy phone-in options for refills, but imposed low controls for tracking medication use. “This step is consistent with patient safety and high quality care,” he said.
Vicodin manufacturer AbbVie said it will comply fully with the requirements and that prescription drug abuse or misuse should be stopped at every level. AbbVie will continue to look into the challenges of patients living with chronic pain and the benefits of access to appropriate pain management, said a spokesperson for the Lake Bluff, Ill.-based pharmaceutical company.
When the comment period for the ruling closed in April, more than 570 respondents had weighed in; 52% were supporters, while 41% were in opposition.
Some, like the American Society of Consultant Pharmacists, worried that tightened requirements would make it more difficult for long-term-care residents to receive adequate pain treatment in a timely manner. The benefits, they said in a letter to the DEA (PDF), “are far outweighed by the risks of creating access barriers and diminishing quality of care for patients suffering from chronic pain.”
The DEA did not consider the negative impact on patient access, said Ross Brickley, past-president of the ASCP. The regulation creates barriers for frail, elderly patients with chronic pain in nursing homes, post-acute and assisted living settings, who need long-term care, he said. The group encourages the DEA and other policymakers to find policy solutions for the new barriers created by the regulatory change.
Others said rescheduling combination hydrocodone products would have “far-reaching consequences, resulting in serious medical and financial hardships,” and that there is no evidence to suggest the change would curb misuse or abuse. “It is highly unlikely that the DEA will achieve the desired outcome,” said a letter sent to the DEA (PDF) in April signed by 11 organizations, including the American Academy of Pain Management, American Pharmacists Association, U.S. Pain Foundation, the Virginia Cancer Pain Initiative and the National Association of Chain Drug Stores.
Calls to these organizations for additional comment were not returned. The National Association of Chain Drug Stores said it is reviewing the decision with members, but could not offer additional comment.
Overdoses from opioid drugs more than tripled between 1990 and 2010, according to the CDC. A JAMA Internal Medicine study published in March found that those at highest risk for overdose from frequent nonmedical use of opioid painkillers were likely to have obtained the drugs from a doctor's prescription. Effort to curb abuse of prescription painkillers has typically focused on infrequent users—those who get the occasional pill for free from a family member or friend.
The Schedule II change, some say, means both physicians and patients will become more aware of the strong potential for hydrocodone addiction. “It's a gateway drug,” said Alesandra Rain, co-founder of Point of Return, a group that helps patients break their dependence on medications like benzodiazepines, sleeping pills and antidepressants. “It's a very powerful drug, but too many people felt it wasn't dangerous.”
Follow Sabriya Rice on Twitter: @MHSRice