Hydrocodone combination products such as Vicodin will now be in the same, more-restrictive category as OxyContin and fentanyl under the Controlled Substances Act, the Drug Enforcement Administration announced Thursday.y.
The rule, which takes effect in 45 days, quickly drew criticism from pharmacist groups serving long-term care residents. The decision prohibits automatic refills of products containing hydrocodone and reduces the number of pills per prescription to a three-month supply, written in 30-day increments.
“It’s a bad idea. We’re disappointed, but we knew the decision was a long time coming,” National Community Pharmacists Association Director of Public Relations John Norton told McKnight’s. “This creates huge access issue for patients with pain, and will be most acutely felt in long-term care.”
The American Society for Consultant Pharmacists past president Ross Brickley, RPh,
said the DEA “did not consider the negative impact on patient medication access rescheduling hydrocodone combination products would cause in the post-acute and long-term care settings. Our members are very concerned for what this could mean for frail, elderly patients with chronic pain.”
The DEA has fought for restrictions on hydrocodone combination products for years, but the agency faced pushback from providers and the Food and Drug Administration. However, last October, the FDA recommended stricter control.
The DEA noted that it received 573 comments, and 40% were against the reclassification. Most of the dissenting opinions came from pharmacists, the agency added.
In response to particular concern about long-term care patients, the DEA noted it “has promulgated many regulations to accommodate the unique circumstances of LTCF residents. For example, in accordance with 21 CFR 1306.11(f), a prescription for a schedule II controlled substance for a resident of an LTCF may be transmitted by the practitioner or practitioner’s agent to the dispensing pharmacy by facsimile.”
But ASCP’s Brickley said the ruling will “magnify existing pain medication access barriers.”
“Where relying exclusively on Schedule II drugs would prevent patients from receiving timely pain relief, access to HCPs in Schedule III had been viewed as an alternative. With this option eliminated, delays to pain relief will increase for post-acute and long-term care patients. This may adversely impact the quality of patient care,” he said.
Click here to read the final rule.