Now that the Drug Enforcement Agency has tightened restrictions on hydrocodone combination products by reclassifying them as Schedule II controlled substances, how should pharmacies prepare for the change?
Now that the Drug Enforcement Agency has tightened restrictions on hydrocodone combination products by reclassifying them as Schedule II controlled substances, how should pharmacies prepare for the change?
Related content: An overview of Rx drug abuse
Jason Poquette, BPharm, RPh, author of The Honest Apothecary blog, recently discussed challenges that pharmacies should anticipate in a piece that appeared on the website Multibriefs.com. The five challenges Poquette said pharmacies will face after the October 6th change are:
1. Storage challenges. Pharmacies are not required by law to store Schedule II controlled substances in locked cabinets or safes, but Poquette recommends they do. “As a pharmacy manager who is charged with the responsibility of securing access to controlled substances, I would insist on having them locked up,” he wrote. “For most busy pharmacies this will require, at the least, another few locked drawers to be available. Where will you put them?”
2. Record-keeping challenges. Individual states may require additional record keeping of the inventory of Schedule II controlled substances. “In Massachusetts, for example, the perpetual inventory must be reviewed and checked by a pharmacist at least once every 10 days (which usually amounts to checking it every week, typically on a weekend),” Poquette wrote.
3.Efficiency challenges. Because prescriptions for hydrocodone products cannot be refilled, each script will have to be reentered as a new one. This will increase the time required to dispense and the time customers will have to wait.
4.Patient counseling challenges. Some prescribers may choose to switch patients to less-restrictive Schedule III drugs. Poquette said this will mean pharmacists will have to counsel patients on the new medications. Poquette said it’s likely that some patients will be dissatisfied with the new medications and will complain.
5. Profitability challenges. As prescribers switch patients to other drugs, the prescriptions for hydrocodone combination products will decrease. “Bean counters in corporate offices may notice some decline in weekly prescriptions and get anxious, putting more pressure on pharmacists and pharmacies,” Poquette wrote.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.