I had an interesting conversation the other day with a journalist. No kidding! I spent about 30 minutes on the phone discussing the recent upscheduling of hydrocodone-containing combination products (HCCP). Here are some of the most common of the 65 brand names and generic medicines affected:
- Vicodin, Vicodin ES, Vicodin HP
- Lortab, Lorcet, Lorcet Plus
- Hydrocodone and one of the following:
- Aspirin (also called ASA)
- Acetaminophen (also called APAP)
- Cough medicines that contains hydrocodone
He was concerned as his grandmother has been prescribed one of these preparations for her pain and wanted to understand how the change could affect her. Great grandson, right? I thought so. So, I tried to explain both sides of the issue that have been in play for several years now. He produced a nicely balanced article in my opinion. I do hope that sharing my impressions with him may have contributed. See what you think.
As I shared this news with my colleagues at TPC, I was reminded that not everyone may be up to date on the changes that have recently occurred. So, if you have not been following the recent turn of events, I will try to summarize it:
- On August 22, 2014, the US Drug Enforcement Administration (DEA) issued its final rule moving hydrocodone-containing combination products (HCCP) from Schedule III to Schedule II under the federal Controlled Substances Act. The DEA’s rule will become effective on October 6, 2014.
- Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, less abuse potential than Schedule I drugs, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous.
- Some examples of other Schedule II drugs are: cocaine, methamphetamine, methadone, hydromorphone (Dilaudid), meperidine (Demerol), oxycodone (OxyContin), fentanyl, Dexedrine, Adderall, and Ritalin
- For other Schedules, see DEA Drug Scheduling.
- Those of you who have an old HCCP prescription with remaining refills will likely experience difficulty trying to get them refilled, beginning October 6, 2014.
- A new prescription will be required. Why? Schedule II medications cannot be refilled.
- Pharmacies will be required to deny the request to fill an old prescription even if refills are indicated.
- They should direct you to contact your prescriber if you do not have a new prescription.
- This could cause a delay in your ability to obtain a new prescriptions and having it filled before you run out of medication. Plan ahead. Do not put yourself at risk for the onset of opioid withdrawal by running out.
- Your prescriber will need to use his/her own judgment on whether to require an office visit in order to obtain a new prescription or just pick it up at the front desk; office visits are not required by law, as long as the prescriber is certain that the prescription is being issued for a legitimate medical purpose, in the usual course of professional practice.
- Refills can no longer be called in to the pharmacy either, EXCEPT in emergency situations, as with other Schedule II controlled substances.
- “In an emergency, a practitioner may call-in a prescription for a Schedule II controlled substance by telephone to the pharmacy, and the pharmacist may dispense the prescription provided that the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period.
- The prescribing practitioner must provide a written and signed prescription to the pharmacist within seven days. Further, the pharmacist must notify DEA if the prescription is not received.”
- Some pharmacies may be reluctant to accept these emergency prescriptions because of the requirement for a follow-up written prescription. If your prescriber is unable to find a pharmacy to accept a phoned-in emergency prescription for a Schedule II medication, he/she will either need to:
- Arrange for you to be seen by a prescriber in a clinic or emergency room;
- Phone in a prescription for a Schedule III (e.g., codeine + acetaminophen) or Schedule IV (e.g., tramadol) opioid analgesic; or
- Phone in a prescription for a non-controlled pain reliever (e.g., an NSAID).
- For those of you who have been given a HCCP prescription with refills in the past, the DEA does provide an option that a supply can be provided for up to 90 days. Following is the section from the DEA Practitioner’s Manual describing a Schedule II “prescription series”:
“…[A]n individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled substance provided the following conditions are met:
- Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.
- The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription—this is known as the “Do Not Fill Until” instructions written on a prescription.
- The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse.
- The issuance of multiple prescriptions is permissible under applicable state laws.
- The individual practitioner complies fully with all other applicable requirements under the Controlled Substances Act and Code of Federal Regulations, as well as any additional requirements under state law.”
Basically, this provision allows a prescriber to issue prescriptions totaling a 90-day supply in a variety of ways: 3 prescriptions each with a 30 day supply; 6 prescriptions each with a 15 day supply; or as many as 90 prescriptions with a one-day supply, if needed.
The ability to do this has been poorly understood by many prescribers, therefore, not frequently used. It is anticipated that with the need to replace a very large number of HCCP refills (about 26 million per year nationwide), the use of this practice just might become more common.
[I would be remiss if I did not give a shout out to one of my favorite pain advocates. Thank-you, Bob Twillman of the American Academy for Pain Management, for making this information so easy to share].
Before closing, I must also share another bit of news that some may have missed. Tramadol (Ultram, Ultracet) was placed in the Schedule IV class by the DEA effective on August 18th, 2014. It joins the ranks with other medications like: Xanax, Soma, Valium, Ativan, Talwin, Ambien.
Please let me know if you experience any hurdles with these changes in regulations and lessons learned so others may benefit.