Article: The Importance of Training and Continuity in Direct-to-Patient Services

When your therapeutic product is delivered and administered to patients at home, how can you ensure that required procedures are executed consistently each time? What if a different nurse or driver is assigned to your patient?

The answer lies in the thorough training of all frontline staff who play a role in relation to Direct-to-Patient (DtP) services.

The nursing partner is responsible for all study- or program-specific training, completed on a country-by-country basis, covering all aspects of the protocol through to Good Clinical Practice (GCP).

To gauge the importance of training for your logistics partner, a thorough understanding of their role is required:

In addition to detailed SOPs related to temperature-controlled packing, shipping, training and DtP, additional SOPs should address issues such as:

• Regulatory compliance for DtP including GxP (Good Practice) adherence
• Patient confidentiality (dispatch, blinding of documentation, invoicing and related requirements)
• Driver communications with patients and nurses
• Packaging and labelling
• Identification of recipients
• Data retention and destruction
• Contingency planning
• Protocol support

Service excellence is only as good as the weakest link. Continuous training and thorough SOPs eliminates any weak links and should be a priority when implementing DtP services.