New ruling changes the way pain medication is prescribed and filled. Everyone using these products should know how this classification will affect them.
The U.S. Drug Enforcement Agency (DEA) has published a new ruling that puts a more restrictive classification on the drug Hydrocodone. All Hydrocodone combination products are being reclassified from the “more permissive” Schedule III to the “more restrictive” Schedule II category. The new drug scheduling will go into effect on Monday, October 6, 2014.
For people who take Hydrocodone combination products (HPCs), this ruling could affect the way their pain medication is prescribed and dispensed. The new 22-page Federal Register Document makes known to the public that any prescriptions for HCPs that are issued before October 6, 2014, and authorized for refilling, may be dispensed in accordance with current Schedule III guidelines, if such dispensing occurs before April 8, 2015. This means that unfilled refill prescriptions that are written before October 6, can still be filled up until April 8, 2015.
Why the Change?
Hydrocodone is in the opioid family, and the intermittent problem with opioids is that opioids are the most effective drug against pain. Opioids are also the most addictive of prescription pain killers because they act similarly to morphine, and that makes them the most deadly.
Since 2007, more prescriptions were written for Hydrocodone + Acetaminophen than any other drug, making it the most widely used pain killer by patients suffering from chronic pain, and the most prescribed drug in the United States. More than 100 million prescriptions per year are written for the pain medication, Hydrocodone.
The reason for the change in scheduling is to minimize the misuse of pain medication for recreational purposes while still ensuring that patients with severe pain will still have access to the amount of drug needed to control their pain and suffering.
Understanding the drug schedules
The scheduling categories of drugs are based on the potential for abuse or misuse to cause psychological or physical dependence, (commonly known as addiction), and whether it has a widely-accepted and current medical use.
The drug scheduling system is a five-category system for controlled substances, Schedule I through schedule V was established by Congress in 1971 with the passing of the Controlled /substances Act (CSA). The job of the CSA is to govern how prescription drugs that have potential for abuse are prescribed and distributed.
Many of our prescription drugs like the ones we take for arthritis and blood pressure are not scheduled, because they are not shown to have any potential for abuse.
For instance, the drug Ecstasy (MDMA), which is a powerful stimulant having the potential for misuse, leading to dependence, has been ruled that ecstasy has no legitimate medical use; therefore the DEA and the FDA have ruled that it should be classified as a Schedule I drug.
But Morphine, also in the opioid family, which has high potential for misuse leading to psychological and physical dependence, is the most effective drug we know of for severe pain, has been classified a Schedule II drug because of its medical benefit.
Hydrocodone is a very effective pain-reliever (analgesic) equal to Morphine when taken by mouth. However Morphine is stronger than Hydrocodone when given intravenously, but their doses are both prescribed based on the “morphine milligram equivalent” because both Hydrocodone and Morphine have a very high potential for dependence.
Opioids are highly addictive and because of their analgesic properties, many people become addicted to Opioids. As an Opioid, Hydrocodone produces a feeling of euphoria. Misusing the drug for its narcotic effects is termed by the medical society as “non-medical use,” that is why Hydrocodone is now classified as a Schedule II drug, and rightfully so. People misusing Hydrocodone for a “non medical use” high will build up a tolerance to the drug and one or two pills a day could become 10 or 20 to get the same effect.
How does the new scheduling affect Hydrocodone?
The new restrictions, effective October 6, will limit the amount of Schedule II drugs available in the drug distribution system to prevent misuse without compromising patients who really need the pain-killing drug medically.
Here’s where it becomes a little complicated. Until the new ruling, all Hydrocodone products were not considered Schedule II. Lower amounts of Hydrocodone per pill (15 mg or less) when combined with another pain-killing drug like Acetaminophen were placed in the less restrictive Schedule III category.
A drug classified in the Schedule III category can be dispensed in many ways. It can be written, faxed, or orally communicated, making it real easy to get a Schedule III prescription drug. Imagine the process like this. Doctor Clayton picks up the phone and calls the pharmacist and say, “Hello, this is Doctor Clayton. Mr. Williams is in my office. I’m going to prescribe her Hydrocodone 7.5 mg, one tablet every six hours as needed for pain, number 75, two refills.” The pharmacy will then transfer the orally communicated prescription into writing, and the process is finished. That’s how easy it is to get a Schedule III drug.
The requirements for prescribing Schedule II drugs are more restricted. To get Schedule II drugs you will have to have a written prescription. However, there are cases that require an emergency oral prescription which is a 72 hour supply. The doctor can write a series of prescriptions that are dated on the same day with a “do not fill until date” up to a 90 day supply. This is considered a prescription and not a refill, so you will not have to see your doctor each month to get a Schedule II drug.
Acetaminophen is not enough to discourage abuse. People with a high tolerance to the Opioid in the combination Hydrocodone/Acetaminophen are likely to get liver damage. Here’s why: It only takes 4,000 mg of Acetaminophen to cause potentially fatal liver damage in some people. Although Acetaminophen is limited to 325 mg in Hydrocodone/Acetaminophen products, it takes only 12 pills to reach the 4,000 mg Acetaminophen level.
The new rule will affect clinics that deal specifically with pain. The DEA alleges that pain clinics are writing prescriptions for patients that they have not actually been seen by a physician. The idea is that the increased recordkeeping requirements of Schedule II should make it easier for the DEA to monitor prescribing patterns and identify prescriber misconduct.
There is concern that Heroin users are substituting Hydrocodone and Oxycodone. On the streets a single pill of Hydrocodone/Acetaminophen costs $5 to $7, a single Oxycodone pill costs $80, and a bag of Heroin costs $15. Any Heroin user will tell you that they would get more “high” for their money from a bag of Heroin.
But the concern of many doctors is that new generation of Hydrocodone users do not start using the drug from pills purchased on the streets. It is believed that new users are getting addicted from extra pills that are lying around the house.
In 2008 the Department of Health and Human Services recommended that HPCs remain on Schedule III. But the increasing numbers of prescription opioid pain killer related deaths prompted the DEA and the FDA to hold a two-day advisory meeting in January 2013 to reconsider the proposal to place all Hydrocodone products on Schedule II. The advisory committee voted 19 to 10 in favor of scheduling all HPCs as Schedule II.
The idea is to make all Hydrocodone products meet Schedule II requirements. It is believed that the new scheduling will discourage prescription fraud, especially telephone fraud, in which knowledge of a prescriber’s DEA number can be used to obtain a Schedule III drug from less-critical pharmacists.
The only change this new rule has is to delete any reference to HCPs from Schedule III. The new drug scheduling of Hydrocodone products will bring stiffer penalties for anyone caught dispensing, selling, trading, or possessing Hydrocodone products illegally.
Note the following changes:
- HCP prescriptions written on or after October 6, 2014 should be treated and filled as a Schedule II controlled substance.
- All hard copy HCP prescriptions must be issued on security paper as of October 6, 20114.
- No Refills may be authorized for any HCP prescription written on or after October 6, 2014.
- No call-in HCP prescriptions are allowed except as authorized in emergencies for C-II controlled substances.
- After October 6, 2014 APRNs and PAs can no longer order or issue HCP prescriptions.
On October 6, 2014, all pharmacies and practitioners should inventory any HCP in their possession or stock by conducting an actual count of each HCP drug. This inventory should be signed and dated and included with the registrant’s biennial controlled substance inventory.
Other than existing requirements for Schedule II controlled substance prescriptions, there are no new limitations or restrictions on how often a HCP can be prescribed. There is no restriction on the quantity of HCPs that can be prescribed on one prescription. Nor is there any new requirement that a patient see a practitioner prior to obtaining a new HCP prescription.