Medication samples serve as a marketing tool for pharmaceutical companies and a convenience for patients, but can be vexing for pharmacies to manage. With the dramatic increase in the use of medication samples over the past 20 years, pharmacy departments are forced to deal with storage regulations and compliance issues.

Proponents of medication samples argue that they provide uninsured patients an opportunity to afford costly medications, allow patients to determine if they can tolerate a medication before purchasing a full supply, and serve as a bridge medication supply until the prescription can be filled at the dispensing pharmacy. Conversely, any medication administered in the hospital must first go through the formulary process to ensure its safety and efficacy; ensuring that every sample has been properly vetted is a problematic endeavor. Various studies over the past two decades have shown mixed results surrounding medication samples.

Applicable Regulations for Medication Samples

Medication samples are subject to significant regulations by a variety of agencies, including state and federal pharmacy and medical licensing boards, as well as accrediting agencies such as The Joint Commission (TJC). From a federal regulation perspective, the Prescription Drug Marketing Act (PDMA) regulates all medication samples to ensure proper distribution and use, while avoiding opportunities for diversion. Under the PDMA, medication samples must be tracked from the distributor through their final disposition. While many pharmaceutical companies have begun to utilize technology to accurately track samples, this practice is less common within pharmacies that have sample oversight. Specific requirements regarding medication sample procurement, storage, control, dispensing, recall compliance, pharmaceutical waste, and donations are detailed in the Food and Drug Administration (FDA) Compliance Guidance Manual. The manual also includes a section focused on reporting instances of diversion, adverse drug reactions, medication errors, and communication of therapy during transitions of care. The pharmaceutical industry is required to adhere to the guidelines set forth by the FDA, as are any health care entities that accept medication samples.

Accrediting agencies, such as TJC, have specific standards that must be met regardless of whether a medication is a sample. The Medication Management standards state that health care entities must have a formulary management system in place, and this applies to medication samples as well. TJC does indicate under each Element of Performance (EP) whether it specifically applies to medication samples. Nevertheless, it is safe to assume that the following areas in the TJC Medication Management standards also apply to medication samples:

• Planning the medication-use system as well as selection and procurement of medications (ie, formulary management)
• High-alert and hazardous medication designations
• Look-alike/sound-alike lists (reviewed annually and updated as needed)
• Written policies that address the control of medications, including safe storage, handling, security, disposition, and return to storage
• Process for handling medications brought into the facility from outside sources
• Policy for weight-based dosing in pediatric populations
• Standardized and proper labeling to promote medication safety
• Dispensing
• Recalls
• Pharmaceutical waste (ie, unused, returned, and expired medications)
• Written policy addressing adverse drug events, significant adverse drug reactions, and medication errors

The health care entity is expected to evaluate the effectiveness of its medication management system, which includes the use of samples. Ideally, policies and procedures should be updated annually or as sites that handle samples are added to the enterprise.

Procurement

The FDA Compliance Guidance Manual includes specific sections that refer to the procurement of medication samples. The manual details the steps that a licensed independent practitioner (LIP) must execute to receive pharmaceutical samples and the exact means by which the samples can be delivered. For example:

• The LIP must submit a request for pharmaceutical samples in writing.
• An entity’s hospital pharmacy can be authorized to handle samples. The request from the LIP must contain the pharmacy name and address for medication delivery. Direct delivery to the hospital pharmacy by an industry representative may also be completed if the written request was signed by the LIP prior to delivery, and the practitioner is acting under their licensure and state law requirements.
• The LIP cannot place standing requests for medication samples or groups of samples. However, requests specifying the number of drugs to be delivered in a period of less than 6 months with delivery dates specified by direct communication are not considered to be standing requests.

It is important to keep in mind that state laws may mirror federal laws or include more stringent requirements.

Safe Storage and Control

The FDA requires that all medication samples be stored under conditions such that their stability, integrity, and effectiveness are maintained. Entities must ensure that medication samples are free of contamination, deterioration, and adulteration. This is not a novel thought regarding medication storage. In the event that any falsification of medication sample records is suspected, notification must be submitted to the FDA within 5 working days in addition to undertaking an immediate investigation. The entity must provide the FDA with a complete written report, including the reason for and the results of the investigation, no later than 30 days after the initial notification.

TJC makes no distinction between medication samples and non-samples regarding proper storage and control. As such, all samples must be stored according to manufacturers’ instructions, and any samples stored in refrigerators are required to have daily temperature logs. TJC also requires inspections of all medication areas on a periodic basis, and this must include medication samples.

It is important to reference all applicable state laws for storage of medication samples. For example, West Virginia law states that medication samples must be stored separately from retail stock. The records of receipt and dispensing also must be maintained separately.

Dispensing

The FDA mandates that the lot or control number be included on the label of the sample unit or individual medication sample. The intent is that the lot or control number will permit the tracking of the distribution for each medication sample unit through to its final destination. Medication samples also must be clearly labeled as such. Refer to state laws for the complete listing of required information on a medication label. Most commonly required are the patient name, medication name, strength, quantity provided, clear directions, date of dispense, drug expiration date, lot number, and cautionary statements/instructions. An entity may consider the addition of significant side effects to the label to assist with patient counseling. TJC also details their requirements in the Medication Management standards.

Recalls and Unused, Expired, or Returned Medications

Recalls for medication samples are to be managed the same as recalls for non-sample medication. TJC states that the organization must safely manage used, expired, or returned medications, including samples. It is particularly pertinent to consider samples any time the entity is reviewing standards and procedures that address pharmaceutical waste and disposal.

Health care entities must plan workflows, processes, and oversight of medication samples in accordance with all federal and state requirements, while also considering their accreditation organization’s requirements.

WVUH Medicine’s Approach

West Virginia University Hospitals (WVUH), the flagship campus of WVU Medicine Health-System, operates a 681-bed facility located in Morgantown, West Virginia, with numerous affiliated ambulatory care clinics. During the last 2 years, annual visits to WVU Medicine ambulatory care clinics have topped one million, an increase of over 30%. While medication samples have been prohibited since 2002, the policy has been re-evaluated frequently due to the onboarding of new clinics, practitioners, and specialty medications.

The primary reason behind WVUH’s decision to prohibit samples was patient safety. We were unable to ensure that every sample utilized within our health system had been vetted through formulary review. In addition, TJC requires that every medication be dispensed by a physician or other licensed practitioner, and every drug administration must be documented in the electronic medical record (EMR). As we could not ensure compliance in meeting these requirements 100% of the time, it was clear that samples had to be prohibited. For those patients who previously benefited from samples, we now rely on manufacturers’ coupons or vouchers.

The successful implementation of this policy change required both administration and physician leadership support. Once these groups understood that accreditation was unattainable under the previous approach, they actively supported the policy change. Both the samples policy and the pharmaceutical representative policy were updated and these changes were communicated to the staff via email.

All medication storage areas at WVUH (inpatient and outpatient) are inspected quarterly by the pharmacy department using a checklist management software program. Pharmacy interns inspect the storage areas located on the WVUH campus as part of their longitudinal requirements, while the medication safety officer inspects all off-site locations. If samples are found at a location, this is documented within the online checklist management software, and a notification is sent to the manager tasked with oversight for that area. All samples are then confiscated for appropriate disposal. Finally, if the manufacturer directly supplied the samples, a formal letter is sent to the manufacturer emphasizing WVUH’s no-sample policy. Clarifying for staff what constitutes a sample can help improve compliance with the policy. We define a sample as any product that P&T would approve to be on formulary. For example, blister packs of acetaminophen qualify as samples, while baby formula does not.

In our experience, interest in medication samples grows when we hire new physicians in support of a service launch or expansion. While it is important to educate these physicians on our policy, we are also cognizant of the fact that manufacturer coupons and vouchers may not be sufficiently available. This can pose significant issues for patients who experience an extended delay waiting for prior authorization from their insurance company. In these cases, pharmacy may consider meeting the physicians in the middle and providing a short-term supply of the medication at no charge to the patients from the discharge pharmacy.

Conclusions

While there are numerous approaches to managing medication samples within a health care system, ultimately, the policy must emphasize patient and employee safety, diversion mitigation, appropriate medication therapy management, and compliance with rules and regulations. When samples are prohibited, the institution should be prepared to justify its reasoning and be willing to re-evaluate this practice with the goal of providing appropriate patient care. If medication samples are determined to be permissible, the institution should ensure that its policies, protocols, and operations meet appropriate standards. Policies and procedures for medication samples should address all aspects of the medication-use process including procurement, storage, dispensing, and disposal, as well as recalls, inspection, and management of pharmaceutical companies and representatives. If a facility does not have the resources to manage medication samples according to these requirements, it may not make sense to allow them.

Maria S. Cumpston, PharmD is the medication safety officer at West Virginia University Medicine. Maria received her doctor of pharmacy from the West Virginia University School of Pharmacy and serves as an adjunct professor at the West Virginia University School of Pharmacy.

Daniel P. O’Neil, PharmD, MS, BCPS, is the assistant director of pharmacy at West Virginia University Medicine. Dan completed his PharmD at Lake Erie College of Osteopathic Medicine and his MS in health-system pharmacy administration at the University of North Carolina Eshelman School of Pharmacy.

Resources

Food and Drug Administration: Food and Drug Administration Compliance Program Guidance Manual. Chapter 56 – Drug Quality Assurance. www.fda.gov/downloads/drugs/ucm342665.pdf (2003). Accessed August 15, 2017.

Electronic Code of Federal Regulations: Title 21 - Prescription Drug Marketing – Samples, Pt. 203 (2017). https://www.ecfr.gov/cgi-bin/text-idx?SID=992ca52e7719775cf1b3256494a37cc8&mc=true&node=pt21.4.203&rgn=div5#sp21.4.203.d. Accessed August 15, 2017.

The Joint Commission: The Joint Commission E-dition Medication Management Chapter (2017). https://e-dition.jcrinc.com/MainContent.aspx. Accessed August 4, 2017.

The West Virginia Board of Pharmacy: Pharmacy Laws And Legislative Rules of West Virginia (Governing: The Practice of Pharmacy; Controlled Substances Act). 2015;20.

SIDEBAR 1
Tips for Improving Control of Medication Samples

1. Create a policy and procedure for storing, handling, and dispensing medication samples.
2. Document lot numbers and expiration dates of all samples upon receipt.
3. Store samples within manufacturer recommendations in an area that is locked and accessible only by licensed staff.
4. If samples are kept in a refrigerator or freezer, maintain a temperature monitoring log or use an automated monitoring program.
5. Schedule routine inspections of samples by pharmacy or clinic staff on a weekly or monthly basis.
6. Keep a log of outgoing products, which encompasses dispensed, expired, and destroyed products.
7. At a minimum, the dispensing log should include the patient name and lot number.
8. Ensure that medication samples are only dispensed by a pharmacist or licensed practitioner and labeled with patient name, medication name, dosage, instructions (frequency, route, etc), date dispensed, and visible lot number.
9. Schedule audits on a monthly, quarterly, or biannual basis to ensure compliance with proper procedures.
10. When updating medication-use policies, remember to include medication samples in the planning and implementation process.

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