Direct-To-Patient Drug Sampling: The Benefits And Opportunities

The Covid-19 pandemic is undoubtedly impacting and fast-tracking many evolutions within our healthcare system. One notable area of interest which has dramatically shifted our perception of care delivery is the rise of telemedicine. This increasingly useful way to conduct patient and physician interactions also brings other elements of care to light, namely, the possibility of Direct-to-Patient drug sampling.

If physicians can now prescribe medication via a telemedicine visit, it also makes sense to streamline the care process even further by allowing patients to receive drug samples directly to their door. The FDA is, for the first time, allowing this level of service to patients for a limited time as we continue to face the pandemic. Direct-to-Patient (“DTP”) drug sampling opens the door for streamlining the drug sample supply chain and automating regulatory compliance while supporting higher levels of patient medication adherence.

We believe that once the benefit of Direct-to- Patient drug sampling is seen during this initial phase, the demand and need for it will continue to grow, creating the real possibility for it to become a permanent offering for patients. To gain a better understanding of why this is an exciting opportunity, we will explore the benefits of drug sampling, address HIPAA requirements, and share key learnings from SymmetryRx’s prescriber survey.

The Importance of Drug Sampling

Drug samples are widely understood to:

·       Provide valuable information about patient response to a new therapy

·       Increase patient compliance: 30% of patients only fill an NRx when provided a sample, regardless of their age, income, or gender1

·       Enable patients to initiate treatment sooner

·       Increase patient satisfaction with the “care” experience2

Starting treatment sooner and saving patients money were the top answers by 197 prescribers in a recent survey of SymmetryRx’s SampleCenter™ users. That is easy to understand with 40% of Americans reporting prescription cost issues3 and the understandable patient anxiety that can come with addressing a previously undiagnosed or untreated condition.

But what is it about sampling that drives medication adherence? We can think of several reasons to explain the reality but increasingly we believe that patient/prescriber concordance – the extent to which patients and their providers agree on whether, when, and how a medication should be taken4 – happens for the 30% of patients who otherwise would not fill their prescription during the sample discussion. Direct-to-Patient drug sampling in the context of telemedicine affords a similar experience and opportunity for the patient and prescriber to engage in the subject of the patient’s well-being.

1. Datamonitor, Introduction to eSampling Solutions, Author: Not available, Published 2006

2. Physician’s Desk Reference, Summary of Findings; Current Sampling Survey, Author: Not available, Published: Not available

3. Harvard T.H. Chan School of Public Health, Four in 10 Americans say they have trouble paying for drugs or skip prescriptions or cut pills due to cost,

Author: Craig Palosky, Kaiser Family Foundation, Published 2018

4. American College of Preventative Medicine, Medication Adherence Time Tool: Improving Health Outcomes,

Author: Not available, Published 2011

Key Considerations for Direct-to-Patient Drug Sampling

Prescriber Interest in DTP Drug Sampling

Based on the responses to our Direct-to-Patient drug sampling survey from prescribers using our SampleCenter™ online sample request system, we found that there’s a great deal of interest in Direct-to-Patient drug sampling. In fact, we classify 70% of respondents as having high interest, and 30% expressed the very highest level of interest.

The survey also identified the types of samples that prescribers would consider for Direct-to-Patient drug sampling.

Types of samples prescribers are interested in

Furthermore, we found what other materials prescribers would like included in Direct-to-Patient drug sampling shipments. These materials address the educational and financial needs patients have that when met, lead to longer-term medication adherence.

Additional Materials Prescribers Want Included in DTP Shipments

Ensuring Proper Usage

An appropriate concern around Direct-to-Patient drug sampling is how physicians can ensure that the drug samples will be taken properly. In a survey conducted by SymmetryRx, we asked physicians this exact question. Respondents could select more than one answer.

·       80% would verbally describe the instructions via telemedicine visit

·       23.08% would convey the information through an online patient portal visit

·       24.62% would send instructions via email

·       7.69% would provide instructions through U.S. mail

·       13.85% responded with “Other”

These findings show that physicians have confidence in being able to communicate how to properly take a drug without needing an in-person visit.

Regulatory Due Diligence

The main obligation for Direct-to-Patient drug sampling under HIPAA is the managing and safekeeping of a patient’s Protected Health Information (PHI).

As the transaction facilitator of the Direct-to-Patient drug sampling process, SymmetryRx has the Business Associate Agreement, data security protocols, and incident detection services to meet our HIPAA obligations. Beginning with gathering PHI from prescribers through sending these details to pharma manufacturers, we use best security practices to protect this data using AWS Cloud Services and secure data transmission protocols.

Additionally, we have a thorough incident reporting protocol should someone illegally access this data. We also have appropriate systems to counteract an attempted or an actual breach, if it were to occur. Providing compliant services requires regulatory vigilance. To this end, SymmetryRx is contracting with a healthcare specialty law firm to provide Direct-to- Patient regulatory surveillance at the state and federal levels. Doing so will allow SymmetryRx to adapt to new state and federal guidelines for continued compliance in our execution.

Concerning package security, SymmetryRx will recommend best practices to pharma sample fulfillment operations from our research and the mail order pharmacy industry.

Conclusion

Drug sampling supports medication adherence. Medication adherence saves hundreds of thousands of lives and hundreds of billions of dollars. The dramatic shift of the care setting to online telemedicine requires a change in how drug samples are delivered: Direct-to-Patient. SymmetryRx has the answers to get sampled drugs where needed through a secure and HIPAA-compliant process.

Our system design requires pharma manufacturers to implement readily available/commonly used data security tools for sample request form access. In addition, SymmetryRx’s Direct-to-Patient sample request process design incorporates a 100% electronic transaction based on SymmetryRx’s innovative PDMA and 21 CFR 11 compliant eSignature process. It takes a few months to contract and set up the Direct-to-Patient service, so start today as you plan to serve prescribers and patients. Reach farther.