Medication samples have often been seen as an avenue to make healthcare treatment more accessible or affordable. After all, if doctors already have access to samples that would help their patients, why wouldn’t they offer them when needed?
Although simple on the surface, the issue of dispensing medication samples to patients has long been in debate in the healthcare industry. Both those for and against the practice acknowledge that there are pros and cons. One of the strongest arguments for continuing this practice is that it can help improve patient outcomes by ensuring immediate access to medications and can contribute to lowering the cost to access essential prescription treatments.
In fact, in response to the COVID-19 pandemic, in 2020, the Food and Drug Administration (FDA) actually loosened regulations on the distribution of drug samples to allow efficient treatment delivery for more patients. However, the state-by-state regulations are often more restrictive and health care providers should ensure they remain compliant.
One major challenge to using samples for providers is that dispensing medication samples can be a logistical headache for staff at clinics, hospitals, and other medical facilities – not to mention the significant potential for legal liability that it poses. Physicians often receive medication samples from various pharmaceutical companies, making it difficult to consistently store, track, and dispense these medications per state and federal regulatory mandates.
This article discusses the benefits of using samples in patient care in more detail and identifies key risks. We then explore five best practices to improve the safety and efficiency of inventory management of drug samples.
The Benefit of Dispensing Medication Samples to Patients
Medication samples are an incredibly common way for pharmaceutical companies to market to and maintain relationships with physicians. Around 50% of clinicians have reported weekly visits from drug reps and 60% overall maintain a supply of drug samples they have received from pharmaceutical manufacturers. This allows health care providers to stay current on the most recent updates with regards to safe and effective product use.
Treating patients with medication samples has historically been shown to:
- Allow treatment to begin faster.
- Improve likelihood of filling prescription and support long-term patient compliance.
- Provide medication for interim time to allow low-income patients to apply for pharmaceutical product assistance.
- Allow healthcare providers to assess a patient’s initial response to a specific medication at a lower cost for them and the patient.
However, achieving those benefits by providing patients with drug samples comes with its challenges – particularly the increased safety risk to patients due to inconsistent tracking and storage of medication samples.
The Risks Involved When Dispensing Medication Samples
The same regulations and safety guidelines apply to medication samples as they would for any other prescription drug. But because they’re typically received directly from manufacturers at no cost, clinicians don’t always have the same procedures in place to protect patients from harm or their practice from legal liability.
It can be easy for medical staff to view medication samples as “outside” the normal prescription process. They’re often dispersed as free or discounted for patients and stored separately from medications used for normal prescriptions. There is widespread agreement that storing drug samples in an unorganized cabinet without proper tracking and handing them out as needed is a recipe for disaster.
However, not all practices have the bandwidth to manage tracking, labeling, sorting by expiry date and ensuring all recalls are identified and removed, leaving patients at risk. Instituting a process that consistently tracks medication samples can be challenging, as they’re often not included as part of most medication inventory management systems.
Although the Prescription Drug Marketing Act (PDMA) requires all medication distributed within the United States to be tracked — including drug samples — only recently have pharmaceutical companies begun to track the distribution and delivery of the samples they send directly to doctors and the clinics and hospitals where they work. As a result, samples are much more likely to be dispensed in ways that promote misuse, and they become more difficult to trace in the event of a manufacturer’s recall.
Challenges to compliant, safe, and effective sample programs:
- Documenting lot and expiry to each patient in case of adverse event or future recall and checking FDA recall lists before distribution
- Tracking proper medication disposal if not dispensed to a patient.
- Ensuring proper storage (including temperature reporting if refrigerated or frozen) and providing inventory tracking to ensure that medications are not dispensed without proper provider approval.
- Providing appropriate patient education for medication usage
- Ensuring medication is sample medication is documented on the patient record and evaluate indication, comorbidity-, or polypharmacy- contraindications.
Medication Sample Management Better Practices
To use medication samples effectively, clinicians need to develop an organized system to manage medication sample disbursement. That system needs to address key components of safe medication management:
- Proper documentation and tracking capabilities.
- Established procedures for receiving medications.
- Authorized disbursement and access.
- Proper storage and disposal.
Let’s take a look at five ways to improve patient safety when managing medication samples for patient treatment.
1. Track all samples by lot, NDC and expiry date
According to FDA regulations, medication samples should be properly labeled, and tracked by lot, NDC and expiry date. Including this information on the label allows manufacturers and clinics to track the distribution of medication samples from a specific lot, which can be particularly critical in the event of a recall.
AccuShelf inventory management software helps clinics establish standardized procedures for receiving and tracking drug samples received by pharmaceutical reps. The AccuShelf inventory management system is the only software solution with a full database of medications samples for easy tracking. Complete with recall and expiry notices, the AccuShelf inventory management system automatically notifies personnel if a drug sample has expired or been recalled to streamline the process without additional manual work.
2. Ensure consistent record-keeping for dispensing and disposing of medication samples
Just like with non-sample drugs, medication samples should be dispensed, tracked, and disposed of according to any applicable state and federal safety standards.
Medical facilities should maintain consistent logs that detail all relevant information, including:
- Date received.
- Data dispensed (or disposed of).
- Prescribing clinician’s name.
- Quantity and dosage dispensed.
- Date dispensed.
Additionally, administrators and compliance officers should conduct regular audits scheduled to review these records to ensure consistency and accuracy of the information.
With the AccuShelf inventory management system compliance audits on medication samples can be fully automated. The AccuShelf Inventory Management System, allows you to capture every detail about drug samples just by scanning them. All medication sample dispenses and transactions are fully searchable, simplifying record-keeping for audits. The system automatically creates a full audit trail for each drug sample transaction and provides federally compliant temperature logs.
3. Follow storage guidelines from medication sample manufacturers and limit access for authorized uses only
While this best practice may seem obvious, storing medication samples according to the manufacturer’s requirements is essential to maintain the drugs’ integrity and effectiveness. Storage requirements should be confirmed for each type of medication sample received. Additionally, all drug samples should be secured and accessed by only authorized personnel.
The AccuShelf Inventory Management system comes with a biometric secured user-access to ensure only authorized personnel can dispense samples.
4. Provide appropriate patient education for medication usage
When prescribing medication samples it’s imperative that healthcare providers provide thorough patient instructions that detail what patients should expect to experience when taking the medication, as well as guidance on when and how to take the correct dosage. And when this information is provided, the patient’s informed consent should be documented as well.
These responsibilities generally fall to pharmacists, which is why developing and documenting well-defined processes for medication sample management is so important.
5. Thoroughly document and monitor patient health outcomes over time
By creating systems to consistently track medication samples, healthcare providers can also more effectively assess the impact of those medications on their patients. When standardizing processes and procedures for medication intake and dispersal clinics can more readily implement patient monitoring that keeps track of how prescribed samples impact health outcomes.
Keeping track of the prescribed medication strength, manufacturer, provided instructions, and lot number is already considered a critical part of medical record documentation for standard pharmaceutical prescriptions. By incorporating barcoding and automated inventory management into medication sample intake and storage, clinicians can significantly improve the safety and efficiency with which they prescribe drug samples to their patients.
AccuShelf inventory management system can integrate with EHRs to maintain proper patient records. The system will then transmit information back to the EHR, documenting medication details into the patient chart, including the dosage, lot, expiration, and administered time, ensuring accurate patient records.
Protect Your Patients and Optimize Your Practice with AccuShelf
With AccuShelf, your clinic has access to medication sample inventory management that enhances patient safety while simplifying inventory control. Unlike many other inventory management solutions, the AccuShelf database features a robust collection of medication samples, allowing your staff to immediately track critical information like lot numbers, manufacturers, and expiration dates.
TruMed Systems continually adds new medication samples as they arise, ensuring that the AccuShelf drug sample database remains current – helping your practice safely disperse these medications while saving time and money. Schedule a demo to see how the AccuShelf system can benefit your practice.