Please note, this newsletter applies to the following programs: RHC
Rural health clinics face the question of whether to carry sample medications. The effort to service the local population, combined with the ever-changing landscape of healthcare, makes this a site-specific decision. Safety and accountability are critical aspects that merit attention and the handling and tracking of sample medication involve stringent compliance.
There is neither a QUAD A standard nor a requirement in the RHC State Operations manual that specifically addresses sample medications. However, medications and biologicals as a whole are mandated by QUAD A standard 14-F-8, which states: The clinic's policies include rules for the storage, handling, and administration of drugs and biologicals.
This QUAD A standard is cross-referenced to the Centers for Medicare and Medicaid Services State Operations Manual for Rural Health Clinics at 42 CFR §491.9 (b)(3)(iii)
“The RHC must have policies and procedures that are consistent with State and Federal law to address how drugs and biologicals are stored and secured, including who is authorized access to the drug storage area. Drugs and biologicals must be stored in a secure manner to prevent unmonitored access by unauthorized individuals. Drugs and biologicals must not be stored in areas that are readily accessible to unauthorized persons. For example, if medications are kept in a private office or other area where patients and visitors are not allowed without the supervision or presence of a healthcare professional, they are generally considered secure. Areas restricted to authorized personnel only would generally be considered “secure areas.”
RHCs are permitted flexibility in the storage of non-controlled drugs and biologicals when delivering care to patients, and in the safeguarding of drugs and biologicals to prevent tampering or diversion. An area in which staff members are actively providing care to patients or preparing to receive patients, i.e., setting up for injections, would generally be considered a secure area. When a patient care area is not staffed, both controlled and non-controlled substances are expected to be locked, in accordance with state and Federal law.”
If your RHC chooses to dispense sample medications, please ensure the following:
o There is a policy on sample medications and how to monitor them for appropriate storage, security, and track samples to prevent inappropriate access and loss.
o A process to inventory the sample medications on hand, including the following:
— Date received
— Medication
— Dose
— Quantity received
— Lot number
— Expiration date
o When dispensing sample medications, the patient's name, the date, name of the medication, dose, quantity, lot number, and expiration date must be tracked.
o A process to reconcile medication inventory.
o The sample medications provided to the patient must be documented in the patient’s clinical record.
o The sample medications provided to the patient must include a label that includes the patient’s name, medication name, dose, and instructions for the medication.
o There must be a process in place to recall medications dispensed to patients in case of a medication recall.
Lastly, please follow state and federal guidelines for disposing of expired medications and maintain logs in the administrative files.
Adopting procedures for managing sample medications, emphasizing accurate documentation and compliance with regulations, and advocating for best practices help your facility align with the overarching goal of achieving the best possible health outcomes.
Since 1980, QUAD A (a non-profit, physician-founded and led global accreditation organization) has worked with thousands of healthcare facilities to standardize and improve the quality of healthcare they provide – believing that patient safety should always come first.
