3.1 Controlled Substances & CURES PDMP

Introduction to CURES and Controlled Substances in California

The Controlled Substance Utilization Review and Evaluation System (CURES) is California's Prescription Drug Monitoring Program (PDMP). CURES is maintained by the Department of Justice (DOJ) and is a critical tool for pharmacists and prescribers to prevent prescription drug abuse, doctor shopping, and diversion. According to Health and Safety Code (H&SC) § 11165, the CURES database tracks all Schedule II, III, IV, and V controlled substances dispensed in California. The system represents a centralized database that allows healthcare professionals to review a patient's controlled substance prescription history before dispensing or prescribing additional medications.

Pharmacists and prescribers are required to register for CURES access upon receiving their licenses. Understanding the intricacies of the CURES system is a fundamental requirement for the CPJE and for practicing pharmacy in California. It is not just a regulatory requirement but a clinical imperative to ensure patient safety and prevent overdose. The data maintained in CURES is strictly confidential and is exempt from public disclosure under the California Public Records Act. Pharmacists must never share CURES reports with anyone other than the patient (under specific circumstances), other healthcare providers treating the patient, or law enforcement with a valid warrant or subpoena.

Mandatory Prescriber CURES Consultation (H&SC § 11165.4)

Under H&SC § 11165.4, prescribers are subject to a mandatory duty to consult the CURES database before prescribing, ordering, administering, or furnishing a Schedule II, III, or IV controlled substance to a patient for the first time, and at least once every six months thereafter if the controlled substance remains part of the patient's treatment plan.

There are several exemptions to this prescriber mandate. For instance, a prescriber is not required to check CURES if the patient is admitted to an inpatient facility, hospice care, or if the drug is administered in an emergency room where the quantity does not exceed a non-refillable seven-day supply. Another exemption applies if the prescriber is treating a patient in a skilled nursing facility or if consulting CURES would result in a patient's inability to receive necessary medical care in a timely manner (provided the quantity does not exceed a five-day supply). While prescribers have these mandatory requirements, the mandate to check CURES prior to dispensing does not strictly apply to pharmacists in the same statutory manner. However, pharmacists should use CURES as part of their corresponding responsibility.

Pharmacist Corresponding Responsibility

The concept of "corresponding responsibility" is a cornerstone of pharmacy jurisprudence. While the prescriber holds the primary responsibility for ensuring that a controlled substance prescription is issued for a legitimate medical purpose in the usual course of professional practice, the pharmacist who fills the prescription holds a corresponding responsibility. This means a pharmacist cannot simply blindly fill a prescription just because it is written on a valid security form. If a pharmacist knows or has objective reason to know that a prescription is not issued for a legitimate medical purpose, they must refuse to fill it.

Signs of illegitimate prescriptions, often called "red flags," require the pharmacist to investigate further before dispensing. Red flags include, but are not limited to:

• The patient traveling long distances to the prescriber or the pharmacy.
• The patient insisting on paying cash despite having insurance.
• Early refill requests or requesting specific brands or formulations (e.g., "promethazine with codeine").
• The patient receiving prescriptions from multiple doctors (doctor shopping).
• Prescriptions for drug combinations known to be abused, such as the "Holy Trinity" (an opioid, a benzodiazepine, and a muscle relaxant like carisoprodol).
• Irregularities on the prescription form itself, such as altered quantities or directions.

When faced with red flags, the pharmacist's duty is to resolve them. This typically involves reviewing the patient's CURES report, interviewing the patient, and contacting the prescriber to verify the prescription's legitimacy. If the red flags cannot be resolved to the pharmacist's professional satisfaction, the pharmacist must decline to dispense the medication. Failure to exercise corresponding responsibility can result in severe disciplinary action by the Board of Pharmacy, including license revocation, as well as criminal charges.

1-Working-Day CURES Reporting Requirement (H&SC § 11165(d))

Pharmacies and dispensing prescribers must report the dispensing of Schedule II, III, IV, and V controlled substances to the CURES database. Under H&SC § 11165(d), this reporting must occur within one working day after the medication is released to the patient or the patient's representative. A "working day" typically means Monday through Friday, excluding state holidays.

The prompt reporting is essential to ensure that the CURES database contains real-time, accurate information for other healthcare providers. The data submitted must include specific elements such as the patient's name, address, telephone number, date of birth, gender, the prescriber's DEA number, the pharmacy's NPI and DEA numbers, the NDC of the drug dispensed, the quantity, the days' supply, the prescription number, the date written, and the date dispensed. Pharmacies usually use automated software to transmit this data, but the pharmacist-in-charge (PIC) is ultimately responsible for ensuring compliance. If a pharmacy does not dispense any controlled substances on a given day, some systems require a "zero report," though California regulations primarily focus on ensuring all actual dispenses are reported within the one-working-day timeframe. Failure to report in a timely manner can lead to citations and fines.

Schedule II Emergency Oral Prescriptions

Generally, Schedule II controlled substances require a written prescription on a specialized California security prescription form. Electronic prescriptions for controlled substances (EPCS) are also valid and highly encouraged (and largely mandated, with exceptions). However, in emergency situations, a pharmacist may dispense a Schedule II controlled substance based on an oral authorization from a prescriber.

An "emergency situation" is strictly defined as a situation where the immediate administration of the controlled substance is necessary for proper treatment, no appropriate alternative treatment is available (including drugs in lower schedules), and it is not possible for the prescriber to provide a written or electronic prescription prior to dispensing.

The emergency oral prescription for a Schedule II drug has several strict conditions:

1. The quantity prescribed and dispensed must be limited to the amount necessary to treat the patient during the emergency period (e.g., a 7-day emergency delivery limit in certain contexts, though federal law says "amount adequate to treat").
2. The pharmacist must immediately reduce the oral prescription to writing, including all required information except the prescriber's signature.
3. The prescriber must provide a valid, written security prescription (or EPCS) to the pharmacy within 7 days of authorizing the emergency oral prescription. The prescription must have "Authorization for Emergency Dispensing" and the date of the oral order written on its face.
4. If the prescriber fails to provide the written prescription within 7 days, the pharmacist MUST notify the California Bureau of Narcotic Enforcement (BNE) in writing within 144 hours (6 days) after the 7-day period expires, and must also notify the DEA. Failure to notify the authorities voids the pharmacist's authority to accept future emergency oral prescriptions from that prescriber.

Summary Table of Controlled Substance Rules