Navigating the regulatory landscape

Regulations governing home healthcare and DtP distribution vary worldwide. In some countries for instance, only physicians — not nurses — can draw blood from patients under 18 years of age in their home. In other countries, intravenous (IV) infusions cannot be given in the home. Conversely, more flexible regulations in some countries allow nurses to perform in-home a wide range of procedures they are trained and capable of doing (along with the appropriate equipment).

Strict rules also apply to the credentialing and documentation of nursing staff and, similarly, differ by country. While all nurses must, of course, meet local professional licensing requirements, do their individual names appear on the protocol application, or simply the name of the home nursing organization? Are nurses legally required to sign the delegation log, or are patient referrals by a physician adequate? Whose names should appear on the FDA 1572 Investigator’s Statement? What other conventions apply in other countries?

From a logistics perspective, regulatory requirements and import procedures related to IMP and other therapeutic products also vary widely from country to country and are subject to change.

Unique to DtP, however, is the fact that different countries have distinct regulations concerning drug dispensing for in-home use. Can a central pharmacy dispense? A site pharmacy? Or can they be collected directly from a licensed storage depot? Again, the answer will vary depending on the country in question. The recommendation is that appropriate descriptions of the DtP distribution strategy also be included in the protocol submission, typically with pre-approval from the local health regulatory body or other competent authority.

As an example, one pharmacy with years of experience in a European country recently got itself into a regulatory tangle when a difference in interpretation of medicinal product and pharmacy laws between the country’s health authority and the federal inspectors. Due to this misalignment, they were forced to cease pharmacy to patient services despite having been compliantly doing so for years prior. What caused this? Lack of regulatory alignment for direct-to-patient deliveries in national legal framework versus the EU’s for clinical trials. 

All these regulatory considerations — shaped by the geographical realities of the study or commercial distribution — factor into the decision to adopt a DtP approach. As a relatively new model, it is conceivable that DtP may be subject to closer scrutiny by regulatory agencies than traditional clinical and commercial distribution models that have existed for decades.

It’s got to be fast, it’s got to be controlled

When it comes to delivering directly to patients, ‘on time’ and ‘in perfect condition’ are imperative. Consider the potential impact of failure should the product arrive late or suffer a temperature deviation. What if:

• The drug is no longer viable?
• A dosage is missed or compromised?
• The patient’s health suffers as a result?
• Drug replacement results in significant costs (high value or in short supply)?
• The nurse’s schedule changes?
• Treatments need to be rescheduled?
• Credibility is lost in the eyes of the patient, nurse, or investigator?
• Patient and nurse frustration affects their interest in the program?
• A missed or delayed treatment disqualifies the patient or compromises the study results?

There are many variables within a DCT setting. DtP demands that pick-ups and deliveries happen within a predetermined — and often extremely tight — time frame and potentially over long distances. As with any pharmaceutical shipment, the integrity of the temperature control is incontrovertible. For DtP shipments, the impact of an early or late delivery is indeed highly impactful on the patient and trial.

Patient confidentiality a priority

Recognizing that patient confidentiality is the cornerstone of ethical healthcare, countries worldwide embrace and adhere to patient privacy laws similar to HIPAA or the EU’s General Data Protection Regulation (GDPR). Knowledge of all local patient privacy requirements and your partners’ ability to suitably support their adherence are of paramount importance within DtP. Adding to the challenge is the need to maintain patient anonymity during clinical trials and appropriately limit unnecessary outside access to information.

For those considering DtP, confidentiality is a very real and understandable concern. Operationally, however, it presents unique challenges. How do you assure accurate collaboration between the dispensing site and logistics provider — respecting patient confidentiality while delivering the correct medication to the correct patient and ensuring no unblinding of information to other parties such as the sponsor or CDMO.

Or, on international shipments of patient samples, how do you accurately identify the ‘shipper’ on the commercial invoice while protecting patient confidentiality and adhering to customs regulations? The answers to these and similar questions will define and inform your DtP strategy.

Bringing calm to complexity

All studies and therapeutic distribution programs are complicated, consisting of many moving parts. DtP adds another dimension as external partners take on many of the responsibilities traditionally assumed by clinicians. What should you look for as you attempt to integrate DtP into your study or commercial delivery system? How can you ensure you have an appropriate degree of control once the study rolls out? How will you know you have selected the right partners?

World Courier offers the solution to DtP trial logistics. Harnessing World Courier’s unique global logistics infrastructure and network optimizes the delivery of treatments to and from patients and reduces the risk of unforeseen issues for clinical trial sponsors. World Courier provides the end-to-end support needed to deliver an effective and successful central dispensing model for your DtP solution.