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Stricter Rules Binding Prescription and Disbursing Controlled Substance Drugs

The new regulations rolled out from January 2021 sets stricter compliance policies for controlled substance prescribers and pharmacists. Here is an understanding of what will keep pharmacists safe from violating the rules.

Pharmacists are aware of the controlled substance prescription and their legitimate use for certain specialized illnesses. The responsibility of prescribing drugs and dispensing drugs is shared both by the practitioner and the pharmacist. The Drug Enforcement Administration, DEA controlled substance regulation and Federal Controlled Substances Act (“CSA”) have guidance that expects the pharmacist to exercise professional judgement on the prescription's legitimacy before the substance is dispensed to the patients.

Prescription compliance and dispensing procedure have been bound in new compliance requirements by the State board Pharmacy and DEA. In California, the controlled prescription should carry identifying markers. After 2019 January all prescriptions should carry a serial number. This is done to check the use of fraudulent prescriptions from pads that become difficult to track or identify.
 

The new rule circulated on January 1, 2021, lays down that all prescriptions must be on tamper-resistant forms and inclusion of 12 characters in the serial number with a bar code linking to the Controlled Substance Utilization Review and Evaluation System (CURES). The bar code should comply with the National Council for Drug Program (NCPDP) and federal state norms.

Electronic prescription forms will become mandatory from 2022 after the Assembly bill is passed, which will enable healthcare to prescribe electronically transmitted prescriptions. This will apply to both non-controlled and controlled substance drugs.

The rule also adds that the loss or theft of a tamper-resistant controlled substance drug prescription should be reported within three days of the theft or loss to the Californian Department of Justice (DOJ) with a law enforcement agency report number when the form is submitted to CURES.

The prescriber needs to notify from their CURES account by email to the designated DOJ email address. Another notification should be provided to the California State Board of Pharmacy which maintains a directory on the lost or stolen prescriptions. CURES tracks all pharmacies in the state of California that dispense controlled drugs. The data is managed by the DOJ. CURES registers the details like patient’s name, prescribers name, the name of the pharmacy, drug, dosage. The database would easily identify any person who is going to doctors to obtain prescriptions for drugs that can easily be tracked. According to the CURES rule, the dispensing of controlled medication should be reported within one working day either to the patient or the patient’s representative. According to the new codification of health and safety rules, the pharmacies should educate and train their staff to update policies. All prescription pads must be approved by the DOJ security prescription printer which has to be kept under lock and key and must remain under the control of the prescriber.

For keeping updated and complying with the new rules set for the pharmacists that fall under the DEA controlled substance regulation, you can visit https://titangroupdea.com With help from the Titan Group, you can focus more on your work while they take care of all the formalities that are required to comply with the Government rules.
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