| Hydrocodone Products Move to Schedule II Controlled Substances October 6, 2014 |
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by Janice Hoffman, PharmD, CGP, FASCP As most of you have heard, Hydrocodone containing combination products are moving to Schedule II controlled substance status on October 6th, 2014 whether as health professional we agree or not. Pharmacologically, Hydrocodone is metabolized to hydromorphone, a schedule II opioid, and also have similar mechanisms of action to other schedule II opioids including oxycodone, morphine, and fentanyl, suggesting that abuse potential would be comparable. 2 The FDA provided support for its conclusion that: (1) Individuals are taking HCPs in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community; (2) there is significant diversion of HCPs; and (3) individuals are taking HCPs on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs. 2 Here are some common questions and answers about the rescheduling of Hydrocodone to Schedule II: 1) What happened to refills that are left on the prescription as a Schedule III filled prior to October 6th? Under prescriptions filled under the Schedule III controlled substances status for a hydrocodone combination can be refilled up to 5 times in a 6 month period. For prescriptions issued under the Schedule III status, BEFORE October 6th, 2014 and with authorized refills, these refills can be legally dispensed prior to April 8th, 2015 as this is a completion of the active prescription.1 That being said, some pharmacists may request a new prescription under Schedule II as there is concern about the record-keeping and CURES monitoring. 2) Will this mean more provider office visits for patients? Yes and No. The patients will need a new prescription every 30 days. How the provider handles the prescription process is up to the provider. Please remember that a provider has the ability to write a series of prescriptions that are dated on the SAME day with a “DO NOT FILL DATE UNTIL” up to a 90-day supply. These are not a refill per se but each original prescription acts like a refill to decrease the number of provider office visits.3 3) How will this affect LTCF? The Controlled Substance Act (CSA) requires that prescriptions for schedule II controlled substances be written, except in emergency situations as defined by the HHS. 21 U.S.C. 829(a). Pursuant to 21 CFR 1306.11(d), in the case of an emergency situation, a pharmacist may dispense a schedule II controlled substance upon receiving oral authorization from a prescribing individual practitioner provided that the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing individual practitioner).2 The DEA recognizes the unique challenges and issues pertaining to handling and using controlled substances at LTCFs and has previously addressed these issues within the limits of the Controlled Substance Act. For example, a prescription for a schedule II controlled substance for an LTCF resident may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. 21 CFR 1306.11(f). In addition, a prescription for a schedule II controlled substance for an LTCF resident may be filled in partial quantities to include individual dosage units. 21 CFR 1306.13(b).2 4) Will the NDC numbers change? Yes there will be new NDC numbers and labeling changes as well as enhanced Schedule II record keeping and storage requirements. CURES will be watching closely for trends in prescribing habits and more visits to providers may be seen. 5) How much is the estimated abuse of Hydrocodone with acetaminophen? Hydrocodone products are the most prescribed drug in the United States. According to the 2012 National Survey on Drug Use and Health (NSDUH), approximately 2.6% or 6.8 million people ages 12 and older are nonmedical users of prescription drugs. Abuse of opioid drugs, including Hydrocodone, can lead to addiction, respiratory depression, and death. There were more than 16,000 deaths due to abuse of opioid drugs including Hydrocodone in 2010. That is more than 1,333 people dying each month. According to the CDC, 38,329 people died from a drug overdose in the United States in 2010. Of these deaths, 22,134 people or 60% involved prescription drugs. Seventy-five percent of the prescription drug overdose deaths (16,651 people) were due to opioid drugs primarily containing oxycodone, hydrocodone, or methadone.2 References: 1. http://www.pharmacist.com/hydrocodone-moved-schedule-ii-dea-final-rule 2. http://www.gpo.gov/fdsys/pkg/FR-2014-08-22/pdf/2014-19922.pdf |