Siteless: Centralization of Information and Expertise
Posted by: Gerald “Pharmacist Jerry” Finken, RPh, MS
Throughout history and human existence, the need to centralize our efforts has enabled us to develop and grow. Communities have developed and grown through the sharing of work, but more importantly by providing safety for its citizens. In the old days, safety was about protecting our communities from wild animal attacks and outlaws. In today’s big-small world of competing governments, terrorist organizations and environmental changes, providing safety has become more centralized and is managed and implemented by the brave and capable men and women in our armed forces, fire departments, police departments and emergency response teams.
Most protection services rely on technology, which has empowered us to provide even greater safety by reducing risks, both actual and perceived, albeit creating new risks; e.g., privacy, cyber-attacks, mis-information, etc. Technology has also helped us to create global communities by decentralizing services that may have once been required to be a direct service.
For example, the security monitoring of a person’s home – in the old days it was a detective sitting outside the home in his car – today it is done remotely by a monitoring company in the next town or even country.
Police and fire departments have also found ways to use the centralization of information and their expertise to predict where the next crime or fire may be. In other words, today security monitoring is performed virtually using internet capable motion detectors, fire and smoke detectors, cameras, etc.
The key to the success of these models is that while the monitoring may be virtual, communities and people are still required in the field for implementation of certain services. In this case, the policemen and women or the firemen and women who need to respond to an alarm, in person, where people live.
This is the same for the siteless model which, too, not only uses technology as a tool to remotely monitor and centralize information and expertise, but also relies on the local pharmacist, doctors and nurses to interact with people in their community—where they live AND as they live. This is because technology has yet to address the social needs of many individuals, let alone have the ability and understanding to palpate organs, provide physical assistance, perform an injection or take blood.
One of the most important aspects of the Siteless model is to work with the patient and their healthcare providers locally, but to centralize the gathering of information such that new information and expertise can be shared. This key element of the siteless model was clearly identified as an essential piece of the siteless model when Clinical Trials Research Pharmacists (CTRP®) were using telepharmacy to speak with patients (more than 30,000 patients across various studies) who were taking part in clinical trials. In several cases, a CTRP discovered an issue that was thought, throughout most of the traditional clinical process, to be a non-issue. Had it not been caught, these alleged non-issues would have caused some serious problems for the respective studies. It was
One case that I remember that clearly describes this scenario had to do with how the medication was labeled. The study I am referring to was for a new drug entity (NME) that was treating patients with diabetes. The well-intended instructions on the label read: Take before breakfast and dinner. As a pharmacist, I think that these instructions are clear and concise and just the kind of information the patient needed. Note: the label also stated, “For subcutaneous injection only”. Patients were instructed on how to inject the medication at the clinical site and the CTRP also reviewed the route of administration once the patient was at home. After less than a dozen calls by the centralized CTRP® to patients living in different regions of the US, it became very evident that these instructions had to be amended.
The issue was a personal one for me as I clearly remember when we moved from our farm in Pennsylvania to a suburb, yet rural, community in New Jersey how odd it was that “dinner” moved from the noon hour to the evening hours and the word “supper” became a word I no longer used. As I now know, in the farming communities of the Midwest (and in other locations), dinner was the largest meal of the day which was eaten during the noon hour and supper was the meal consumed in the evening. Thus, patients in the Midwest were taking the medication before their noon meal. The potential impact to the study, I think everyone would agree, would have been significant.
Now, one might argue that this would have been caught at Visit 2 or Visit 3 or when the CRA audited the site, but I disagree. If everyone involved in the trial was local or culturally similar, then why would anyone at the site think that dinner would be supper? In either case the significance of the issue of “if” becoming “when” is irrelevant. The key is that by centralizing the information in real-time the issue was immediately corrected with little impact to the trial. I should also point out that every new patient enrolled was instructed that “dinner” meant the evening meal. The labeling was changed as well.
This is just one example of hundreds of points and issues that were addressed by the centralization of information through the medication expert, the pharmacist. This is what the siteless model will use to ensure a greater number of NMEs are approved the first time. Just as we did with the NME for diabetes.
Let’s ask ourselves, if security companies, police departments, fire departments and other like-services can centralize information for the greater good of communities, why not clinical research using the Siteless model?
What do you think?