Dispensing sample medications is a common practice observed in medical clinics and can benefit both providers and patients. Providers can initiate therapy and trial medications to determine the effectiveness and potential side effects before starting patients on the long-term. Patients can initiate therapy early instead of waiting for insurance clearance or private payment, especially if they are financially challenged. However, despite these benefits, organizations taking a casual approach to managing and dispensing sample medications can create risks that may impact patient safety.
Ensure Established Procedures are in Place for Sample Medication Dispensing
Organizations must ensure that they have established procedures for storage, inventory control, record keeping, education, disposal, and risk management. The laws and regulations for medications found in the organization’s central pharmacy apply to sample medication management. Consulting with your pharmacy leadership about sample medication management practices is essential for safe practice.
Storage and Organization
Sample medications must be stored in a locked, secure location, preferably in a separate area accessible only to authorized personnel. Ensure that access to the locked storage area is controlled, even after the clinic closes for business.
Medications should be arranged in an organized manner, preferably alphabetically by generic name, keeping similar-looking and sounding medications separate to minimize errors. Any hazardous medications should be identified and marked according to the organization’s policies. Staff should know any handling considerations and applicable PPE made available for use. Inventory should be routinely monitored for expiration dates. Stock should be arranged where older medications are dispensed first to prevent expiration.
Storage Conditions must adhere to the manufacturer's temperature, humidity, and light exposure recommendations. Organizations must ensure that these conditions are maintained, which may require temperature and humidity monitoring. If medications are stored in a refrigerator or freezer, ensure regular temperature monitoring is conducted and that there is a system to alert staff if temperatures are outside the acceptable range, including after regular business hours. Organizations should have a plan in place to relocate sample medications if storage conditions cannot be maintained.
Record Keeping
To ensure accurate inventory control, organizations should maintain a log documenting the receipt of samples, including the date received, medication name, manufacturer, lot number, expiration date, and quantity. There should be a process in place that all sample medications received must be channeled through a process that would include placing their receipt on the inventory log. We have observed clients where vendors have handed providers sample medications that they did not include in their inventory, disrupting inventory control.
Likewise, there should be a Dispensing Log where each medication sample dispensed is recorded, including the patient's name, date dispensed, lot number, and quantity. Additionally, any medications removed due to recall or discarded due to expiration/non-use are recorded on the Dispensing Log.
Both Inventory Log and Dispensing Log can be combined into a single document. These records should be kept secured from unauthorized access. Organizations should consult with their Pharmacy staff to determine if their inventory process could be used for their sample medication inventory control documentation process.
The provision of sample medications must be recorded in the patient's medical record, including the same details as the dispensing log. This can support the recall process in the event of a medication recall, where patients who may have received the medications should be identified quickly to initiate contact with the patient.
Dispensing and Patient Education
Organizations should never allow staff to provide samples to anyone without provider orders, provider supervision, and patient record documentation. Sample medications must only be given when prescribed by a licensed practitioner with prescriptive authority. Organizations must ensure that staff obtaining sample medications from inventory and handing them to the patient are authorized to do so by State and Federal Law. Medical technicians may be unable to handle sample medications under your State Law.
Organizations should ensure that sample medications dispensed to patients are labeled with the patient's name, drug name, dosage, frequency, and expiration date, similar to a prescription label. The label should have information about the organization dispensing the medication and contact information.
It is imperative that organizations provide patients with clear instructions on how to take sample medications, including dosage, frequency, timing, and any special instructions or warnings. Staff should thoroughly document all patient education and discussions in the patient's medical record. Pre-printed instruction sheets are an excellent means to ensure consistent instruction and provide patients with a reference they can use at home. Ensure that considerations are made for patients who cannot read or read in a language other than English. Consider translating patient education handouts in languages that support your patient population. Ensure that those providing the patient education are authorized to do so per State and Federal Law.
Recall and Disposal
Organizations should establish a system for identifying and managing drug recalls. The U.S. Food and Drug Administration (FDA) has guidance for recalls, including procedures and sample recall letters for patients, on its website. The organization should ensure its recall process utilizes its inventory control logs to identify patients, validate that the recalled medication was provided, and initiate contact to either have the patient return or destroy the medication per FDA guidelines. Documentation of recall actions should be made to ensure that attempts were made to identify and contact patients and initiate recall efforts.
Disposal of sample medications should follow any State and Federal Guidelines. This would include sample medications that are expired or unusable. Ensure that disposal considers controlling unauthorized access to wasted medications and environmental concerns. Consult with your pharmacy leadership regarding specific guidelines that may affect your practice.
Risk Management
Organizations should regularly review their sample medication management processes to identify areas for improvement. This should include all aspects of the sample medication management process, including storage, inventory control, documentation, and dispensing. Test your recall process to evaluate your process of identification of affected patients. Encourage staff to report concerns and incidents. Survey your patient population to determine their satisfaction with your sample medication processes, including education.
Common findings we observe during a survey of Sample Medication Management Programs:
- Failure to follow applicable state and federal regulations governing sample medications.
- Lack of record keeping (e.g., no logs) for medications received and dispensed.
- Inability to track drug recalls (e.g., not documenting lot numbers).
- Improper storage system (e.g., inattention to manufacturers’ storage recommendations or storing samples alphabetically, which can result in medication errors).
- Improper storage location (e.g., storing samples in exam rooms that are accessible to patients or in areas that are not routinely monitored).
- Failure to secure sample medications in locked storage can result in theft and misuse by patients and staff.
- Failure to label sample medications according to state and federal guidelines, resulting in patient medication errors (including potential confusion by family members, who might take the unlabeled medication in error).
- Expired sample medications.
Summary
Sample medications can provide organizations and patients with an excellent resource supporting effective patient care. Organizations must implement controls and practices that support safe medication management.
For questions or to learn more contact the C&A team at 704-573-4535 or email us at info@courtemanche-assocs.com.
Courtemanche & Associates specializes in Healthcare Accreditation and Regulatory Compliance Consulting Services. With over 30 years of being in business and 100+ years of healthcare experience amongst our consulting team, we are ready to assist with your accreditation and regulatory compliance needs.
