History of Pharmacy Card Use in Clinical Trials

Pharmacy card programs in clinical trials have evolved as a key solution for simplifying the logistics of dispensing medications to participants, streamlining supply chains, and reducing costs and inefficiencies. Here’s a brief overview of the history and development of pharmacy cards in clinical trials:

1. Origins and Early Uses

• Traditional Supply Chain Issues: Historically, clinical trials relied on centralized depots to distribute investigational products to research sites. This process often involved manual handling, lengthy distribution timelines, and inefficiencies, especially for commercially available drugs needed as comparators, rescue meds, standard of care or adjunct therapies.
• Need for Simplification: As the demand in numbers of clinical sites and patients increased, along with the complexity of trials, there was a need to simplify the distribution and tracking of commercial medicines used in trials. This set the stage for the development of pharmacy card programs.

2. Advent of Pharmacy Card Programs

• Pharmacy Benefit Cards: Initially, pharmacy benefit cards were used in commercial settings for insurance and retail medication transactions. In the clinical trial space, this concept was adapted to streamline the process of getting commercial medications to patients.
• First Programs: Paper-based pharmacy cards in clinical trials began to appear about a decade ago aiming to eliminate the need for drug shipments and enable patients to receive commercial medications directly from retail pharmacies.
• CRO Integration: Contract research organizations (CROs) and sponsors saw the benefits of integrating these cards to reduce operational burdens, allowing patients to fill prescriptions at their local pharmacy or through mail-order services.

3. Expansion and Technological Improvements

• Digitization: As the need for real-time data and improved reporting grew, originators of the pharmacy card clinical trial model saw a need for innovation in this sector and SupplyRx was launched. This digitization allowed sponsors and research sites to track patient adherence by site and subject, medication use, and financial data in a more structured and efficient manner.

• Integration with SaaS Platforms: Companies like SupplyRx developed SaaS-based platforms that incorporate pharmacy card systems, linking pharmacies, patients, sponsors, and sites for seamless management of commercial drug dispensing. This has further enhanced transparency, reduced waste, and streamlined reporting for clinical trials.
• Patient-Centric Trials: Pharmacy cards became a critical tool for decentralized and hybrid trials, where patients were no longer required to visit the clinical trial site for every dose or refill. This made trials more accessible, especially for hard-to-reach or underserved populations.

4. Current and Future Use

• Sustainability and Efficiency: Today, pharmacy card programs are widely adopted in clinical trials for commercially available drugs, especially when sponsors aim to reduce the environmental impact of drug shipments and create a more sustainable supply chain.
• On-Demand Reporting: Modern platforms, like developed by SupplyRx, allow for on-demand medicines, financial analysis and patient data tracking, providing sponsors with valuable insights while simplifying compliance and regulatory reporting.? These cloud-based applications make it possible to further integrate with other technologies (RTSM, IRT, EDC, etc.) used for clinical supply and patient management.

In summary, pharmacy card use in clinical trials evolved from traditional paper-based, manual supply chains to sophisticated, cloud-based platforms that improve efficiency, reduce costs, and enhance the patient experience, while making clinical research more accessible.

Author: Brian Horan is the Co-Founder and CEO of SupplyRx.? Please contact him at [email protected] for additional information or a demo of the SupplyRx Platform.