The Controlled Substance Act (CSA) oversees the handling, storage, and distribution of controlled substances in hospitals and independent pharmacies. The United States Drug Enforcement Administration bears the responsibility of regulating these substances and addresses a range of topics, including the transfer and disposal of controlled substances along with how pharmacies must secure them. Every person working in a pharmacy must know the law and ensure they remain in compliance to protect not only the pharmacy and its workers but also the general public.
Securing Controlled Substances
Hospital pharmacies must secure controlled substances to ensure they do not fall into the wrong hands. Many hospitals invest in Automated Dispensing Cabinets (ADC) to achieve this goal. However, it is recommended these cabinets not be located in high-traffic areas. To increase the security of these substances, place them in the locked cabinet inside a locked room, as this makes it more difficult for unauthorized personnel and other individuals to access the substances.
The cabinets provide numerous benefits that cannot be overlooked. For instance, with the help of ADCs, hospitals find they can deliver medications in a shorter period while maintaining greater inventory control. Furthermore, the cabinets often help to reduce medication errors. Nevertheless, hospitals must ensure the use of the cabinets is supported by rigorous policies and procedures. A failure in this area could lead to a false sense of security and problems with securing the substances.
The Transfer and Disposal of Controlled Substances
Pharmacies must know what is permitted and forbidden concerning the transfer and disposal of controlled substances. For instance, a company might wish to know if they can use a third party to assist with inventorying these substances or packaging them before transfer. Fortunately, these tasks aren’t ones a pharmacy will have to do on its own. They can bring a company in to help with the tasks. The same holds when they are transferring or disposing of controlled substances in their custody.
However, controlled substances may only be transferred between entities with valid DEA registrations. Furthermore, the parties must complete all required paperwork associated with the transfer or disposal. If disposing of the materials, the pharmacy must ensure they are working with a company authorized to accept the materials for disposal. These companies are referred to as reverse distributors.
In fact, pharmacies must keep records for every controlled substance that moves through their facilities. This includes substances purchased or received, any controlled substances stored on the premises, those that are distributed or dispensed, and any controlled substances the pharmacy disposes of in the course of normal operations. The records must be complete and accurate at all times.
A pharmacy cannot dispense a controlled substance until it has a valid prescription from a licensed medical professional. This prescription must include the physician’s signature and the date on which the prescription was issued. Furthermore, it must display the physician’s full name and address along with that of the patient. Every prescription includes the practitioner’s unique DEA number. In addition, the prescription needs to show the name and strength of the drug, the appropriate dosage form, how to use the medication, the number of authorized refills, and the quantity. Prescriptions that fail to include this information aren’t in compliance with the Controlled Substances Act.
When a pharmacy dispenses a controlled substance, it must label the medication. This label is required to have the date the prescription was filled, the name and address of the pharmacy, the serial number of the prescription, the name of both the practitioner and the patient, and how the medication is to be used. Furthermore, this label must share any cautionary statements required by the FDA for that medication.
Managing controlled substances in a hospital pharmacy remains crucial. Every person working within the pharmacy must be aware of all laws and regulations to ensure they remain in compliance. Review existing policies to identify any problems or potential problems regularly. Pharmacies that do so ensure they stay on the right side of the law.