Article: How to Implement a Direct-to-Patient Logistics Model
Generally, DtP timelines include the “last mile” to the patient home, yet this
may not equate to a longer time period than delivery to clinical site. Given COVID-19,
additional buffer time is factored due to mobility restrictions in several
countries. We endeavor to keep the timelines as short as realistically possible,
taking also into account the urgency of the DtP shipment.
1. In a DtP setup, are timelines longer for delivery to a patient than they are for delivery to a clinical site?
2. What are the critical parameters to successfully set up a DtP supply chain?
A: In a standard DtP setup, apart from the sponsor’s responsibility to comply with MoH (Ministry of Health) requirements, the critical operational parameters required are:
- Protocol number(s),
- List of countries
- Number of patients
- Location of patients
- Frequency of shipments
- Duration of the study (expected start and end date)
- Temperature conditions
- Packaging and monitoring requirements.
It is also important for us at World Courier to have awareness of any critical shipments that need to be prioritized before a trial is fully setup. In the current COVID-19 emergency scenario, although startup timelines may be tighter, it is even more important to capture these details for a successful implementation of the DtP supply chain.
3. How easy, and how quick, is it to switch from a traditional clinical supply chain to the DtP model?
A: This is a relatively straightforward switch if this is outlined as a potential option in the study protocol. From a logistics perspective, once the operational parameters are known (and once the sponsor has gathered all necessary approvals), this can be switched as soon as the request has been set up in the logistics systems. Many regulators have published local guidelines to accommodate the DtP model to ensure patients continue to receive their supplies. Based on the size, the number of countries, and the complexity of the trial, it can take up to ten days.
4. What are the most common restrictions or challenges when implementing DtP Logistics?
A: Once the regulatory requirements of the MoH are met, the current COVID-19 restrictions are mostly due to limited air freight capacity and access to red zones/ lockdown areas. World Courier has implemented a contact-free and signature-free procedure to ensure the safety of the driver, patient and other supply chain participants. We recommend a thorough study requirements discussion to ensure the processes applied are achievable and fit for purpose.
5. How is patient confidentiality ensured when they sign up for a clinical trial?
A: Patient confidentiality and data privacy and paramount in a clinical study. World Courier has dedicated procedures whereby patient information is anonymized on documentation to respect patient privacy.
6. How can temperature data be recorded for temperature-sensitive materials and can we ensure temperature critical injections are viable through DtP?
A: For deliveries with temperature loggers, there are two different approaches, depending on whether a nurse is present or not at the patient’s home. If a nurse is present as part of the home care model, then the nurse would be trained in the procedure for reading and assessing temperature monitor results. If a nurse is not involved, the driver stops the temperature monitor in respect to contact-free delivery procedures. Regarding injections, the administration methodology would need to be specified in the study protocol, in both scenarios.
7. How is it ensured that the principal investigator is aware of any shipment as overall clinical trial IP responsibility is with him/her?
A: Investigators are often directly involved in the oversight and scheduling of patient home deliveries with us. More often than not, the drug is dispensed from the site pharmacy, where it originates from for delivery to patient homes. When neither of these scenarios is the case, the investigator still monitors the patient dosing schedules and is responsible to ensure the overall care of patients enrolled in clinical studies.
8. Can you share some examples of how hospital pharmacists can adopt the new DtP model, given that pharmacists need to do face-to-face dispensing and provide consultation?
A: Patients who receive shipments of medication at home are likely still to have some site visits. The responsibility of the clinical care and dispensing of the medication is typically owned at the site level, which includes direct interaction with patients face-to-face as well as virtually (e.g. telemedicine).
9. Is there an option for the Sponsor to set up the account and pay the cost of DtP without receiving patient identifiable data?
A: Patient confidentiality and data privacy and paramount in a clinical study. World Courier has dedicated procedures whereby patient information is anonymized on invoices. This allows invoices to include cost overview and controls while also respecting patient privacy.