Category Archives: Pharmacy Law

Operation Faux Pharmacy

The Los Angeles office of the Drug Enforcement Administration announced a plan this week which is aimed at fighting the opioid epidemic and targets pharmacies in Southern California that have been identified as potential violators of the “corresponding responsibility” laws. The DEA’s multi-prong initiative includes obtaining search warrants to search those pharmacy owners’ homes, cars and other locations. As part of this initiative, DEA special agents and investigators make onsite visits to pharmacies and demand the DEA registrant to agree to voluntarily surrender his or her DEA Registration.

Up-Scheduling of all Hydrocodone Products

“Up-scheduling” of all hydrocodone containing products: On August 22, 2014, the U.S. Drug Enforcement Agency (the DEA) published its final rule that places all hydrocodone containing products under schedule II of the Controlled Substances Act. The new “up-scheduling” of hydrocodone as a Class II controlled substance shall take effect on October 6, 2014.

Under the Controlled Substances Act, every controlled substance is classified into one of five schedules. Hydrocodone containing products will remain as a Class III controlled substance until the “up-scheduling” takes effect.

The decision to reschedule hydrocodone was based on its potential for abuse and out of concern for public health. Recent studies have confirmed that there is physiological and physical dependence associated with hydrocodone containing products. There also has been a significant increase in deaths within the last few years associated with the use of opioids and hydrocodone containing products. Tragically, a very large number of young youths have died as a result of overdosing on opioids including hydrocodone containing products.

Corresponding Responsibility Law

What do the corresponding responsibility obligations require a pharmacist to do when a pharmacist is presented with a prescription for a controlled substance drug? A licensed pharmacist has a corresponding responsibility to make sure that a prescription for a controlled substance written by a prescriber is for a legitimate medical purpose. (California Health and Safety Code section 11153(a).) To comply with the corresponding responsibility requirements, and prior to dispensing a prescription for a controlled substance to a patient, a pharmacist is required to conduct a reasonable investigation to access whether the prescription for the controlled substance is issued for a legitimate medical purpose. To do so, the pharmacist, using his professional judgment, is required to assess a number of factors including: (1) whether the prescription is facially valid; (2) contacting the prescriber if there are questions or concerns regarding the prescription; (3) talking to the patient to determine if the patient is on other prescription medications or if the patient has tried other pain prescriptions; and (4) determining where the prescriber’s office is in relation to the pharmacy and to the patient’s residence.

The corresponding responsibility law also requires a pharmacist to review and evaluate a patient’s use of controlled substance prescription drugs. A pharmacist is able to review a patient’s usage of all controlled substance prescription drugs by accessing a state-wide system known as the Controlled Substance Utilization Review and Evaluation System (CURES). CURES tracks controlled substance prescription drug history information for all patients who have received controlled substance prescription drugs in the state. Information obtained from CURES and a pharmacist’s education, training and experience are valuable in preventing prescription drug abuse and drug diversion. For instance, by obtaining information from the CURES system, a pharmacist is able to determine whether a patient is receiving prescriptions for controlled substance medications from more than one prescriber or receiving prescription drugs from multiple pharmacies, circumstances, which if present, would indicate potential drug abuse and, or diversion.

Based on my experience having represented pharmacists in the State of California who were facing disciplinary charges related to the corresponding responsibility laws, I highly encourage all pharmacists to use the CURES system when presented with a prescription for a controlled substance prescription drug. I also encourage all pharmacists to look for what has been described as “red flags” when they are evaluating a prescription for a controlled substance prescription drug. In addition to the above factors to consider, some of the “red flags” to look for are:

• The patient’s age (a relatively young individual presenting a prescription for a strong pain medication)
• Method of payment (cash payment for pain medications)
• Large quantities of controlled substance prescription drugs
• Patients coming to pharmacy in groups
• Patients from the outside of a pharmacy’s trade area (typically outside of a 5-mile radius)
• Pharmacy is a long distance from the prescriber’s office

At the Marcarian Law Firm, we handled some of the most significant corresponding responsibility cases against pharmacies and pharmacists in the state.