Industry alerts patient groups to new schedule of hydrocodone combination products
WASHINGTON — The Drug Enforcement Administration’s final rule moving hydrocodone combination products from Schedule III to the more-restrictive Schedule II officially went into effect on Monday.
The rule change had represented an implementation challenge for retail pharmacy as the industry had only 45 days to become compliant with the final rule. Originally, NACDS had requested 180 days to allow pharmacies to become compliant with the rule.
With 135 million in HCP products dispensed in 2012, according to IMS Health, that represents a significant volume of prescriptions that have to be handled differently both in terms of how the product is stored, as well as how refills are processed.
“The main impact [on retail pharmacy] was getting ready. That was the biggest challenge,” Kevin Nicholson, VP public policy and regulatory affairs for the National Association of Chain Drug Stores told DSN. “We were concerned when there was only a 45-day implementation timeline. Everyone’s ready, [however],” he said. “We’re working hard to implement it and make sure patients have minimal disruption, despite the challenges patients will be facing with the new rule.”
In addition to updating pharmacy systems and supply chain protocols, patients may face challenges in refilling their hydrocodone prescriptions under DEA’s final rule. Prescriptions for these products that are issued on or after Oct. 6 must comply with requirements for Schedule II prescriptions and refills of these prescriptions will be prohibited. However, prescriptions issued before Oct. 6 that have authorized refills may be dispensed in accordance with DEA rules until April 8, 2015. Yet, state law, insurance limitations and some pharmacy quality and safety operations and processes may not allow for these prescriptions to be refilled. “That’s important as well because even though the DEA is saying the refills can still be used, the reality is in many or most cases, the refills will not be able to be used,” Nicholson said.
Moving forward, NACDS has been working with patient groups and physician groups to alert them around what the HCP schedule change means for them. “The biggest challenge [now] is continuing to educate the patients and the doctors so that they know that these medications are now in this more restrictive class — they can’t be called into the pharmacy; they can’t be refilled — and we’ve done a good job with that, too ,” Nicholson said. “We’ve been working with NCPA, the American Medical Association. We’ve been talking with the patient groups [like] the American Cancer Society, Cancer Action Network,” he said. “We want to make sure that no one is surprised by this new requirement.”
The National Association of Chain Drug Stores has also recently placed its support behind new legislation introduced on Sept. 18 — S. 2862, the Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 — which calls for a collaborative, coordinated approach to curbing prescription drug abuse and safeguarding patients.
Introduced by Sens. Orrin Hatch, R-Utah, and Sheldon Whitehouse, D-R.I., the bill would establish a congressionally-mandated report from the Department of Health and Human Services, facilitated in consultation with the Drug Enforcement Administration and the White House Office of National Drug Control Policy, that would identify obstacles to legitimate patient access to controlled substances, issues of diversion of these products, and opportunities to better coordinate federal, state and stakeholder activities that can reduce prescription drug abuse without compromising access to medications for patients who legitimately need them.
The Senate bill largely mirrors the House bill, H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act of 2014, which was introduced earlier this year by Reps. Marsha Blackburn, R-Tenn., and Tom Marino, R-Pa. Also backed by NACDS, that bill passed the House in August.