Technology’s patient-centric vision will revolutionise the approach to patient safety

patient, safety, technology, data

The future of patient-centricity in pharmacovigilance involves a dynamic flow of data and information revolving around patients and enabling them — and their caregivers — to make insights-based decisions about their care. Patient outcomes are about enabling the patient and caregivers with the information they need and opportunities to be heard when accessing different healthcare choices.

What we see today and will see in the future is a significant shift towards organising around patients — and their values and belief systems — not around hospitals, insurance companies, or vendors.

This vision empowers patients to regulate the information they give and receive, and choose what sources to use to make informed decisions. With a patient-centric approach, patients exercise their choices, access actionable, timely information tailored to them, and feel empowered to participate in decision-making. A direct contribution of one patient experience can inform safety for multitudes of patients.

Why is patient-centricity so critical in the pharma industry? Because it leads to better patient outcomes. It increases patient engagement and satisfaction. And it improves pharma companies’ reputations and regulatory outcomes. In short, patient-centricity benefits everyone — and technology helps achieve that goal.

The importance of patient-centricity

Defining patient-centricity is a challenge not unlike attempting to hit a moving target — a conundrum all healthcare providers face. And while physicians may strive to be respectful and responsive to their patients, prioritising patient values while also providing the best, most appropriate treatments, most doctors don’t think pharma succeeds in offering a patient-centric approach.

In fact, only 45% of healthcare practitioners feel biopharma companies embody a high level of patient centricity. Healthcare professionals want pharma to look beyond medicine and embrace patients’ entire healthcare experience — from educating and supporting to addressing social determinants of health (SDOH), like societal and environmental issues.

One solution for improving patient-centricity includes building a single global platform that delivers real customer value and centres the patient. A truly patient-centric, integrated platform hinges on technology enabling everyone in the internal and external teams, the pharmaceutical companies. and the healthcare providers to organise around the patient.

An example of how patient-centricity can work

Meet Rebecca. She’s on a medicine to treat osteoporosis, which requires regular self-injections. During one injection, the needle broke, and now she has some swelling, a rash, and a headache. She needs a replacement quickly, so she can continue to medicate.

In this scenario, Rebecca simply scans a QR code on her injection package. The scan takes her to an app populated with the drug’s formulation and dosages. The app prompts her to describe her side effects and the issues with her needle. She explains she needs a replacement as quickly as possible. The app collects and processes all the data from the QR scan and Rebecca’s input. It asks if scheduling a replacement needle to arrive at her home in several days will work. Rebecca says yes.

But this interaction isn’t over yet. Rebecca remembers that she’s been dealing with a bad migraine and mentions it to the app, which records the information, sends it to the healthcare provider’s platform, and pulls approved medical information to help Rebecca understand her migraine symptoms better.

In this scenario, the app has a pre-consented PCP setup. Rebecca’s PCP is already in the system, and the app asks whether she wants to share her symptoms with her PCP. Rebecca says yes, and the app sends the information to her PCP. The communication between the app and the platform enables Rebecca to get the help she needs immediately.

But the process doesn’t end here.

Rebecca’s alert has also notified the pharma company’s case processor on the internal company safety team. The pharma company’s platform automates alerts and cases coming into the system, processing, coding, and completing the case and using a large language model (LLM) to create a narrative just as a physician would. Rebecca's product complaint is automatically populated, linking the case to the quality event — which the internal case processor verifies.

The internal quality team also receives an alert about the broken needle. The team verifies all QC processes are in place, investigates the risks, identifies potential safety issues, and ensures regulatory compliance. The platform’s linked quality system has automatically created the event, auto-populated the data, and scheduled a replacement for Rebecca’s broken needle.

Remember Rebecca’s migraine? The platform raises another alert to a safety physician to review the information. This physician sees the signal associated with Rebecca’s medication. The platform also allows the physician to see the different evidence sources contributing to the signal — not just ICSR data — but also real-world data and literature. She notices a biosimilar signal for another product her pharma company will soon take to clinical trial. But because the clinical trial team uses the same platform, they already know about Rebecca’s migraine. The doctor continues exploring Rebecca’s health history to determine whether other factors could have caused her migraine.

The story doesn’t end here, either. Thanks to this patient-centric platform, other teams, including those tasked with monitoring literature and screening scientific journals and studies, also have access to Rebecca’s experience. So does the team responsible for regulatory compliance.

This scenario offers the perfect illustration of how technology can help one patient self-advocate and, also, in relaying her information through an app, communicate that information to other teams across a pharmaceutical company to raise awareness of a possible quality issue with the equipment or side effects linked to ingredients used in a particular product.

A patient-centric vision

While the pharma industry cannot influence patients, it can provide patient-centric services. Achieving this vision of patient-centricity requires pharma companies to:

  • Conduct patient-centred research.
  • Develop educational resources.
  • Partner with patient advocacy groups.
  • Offer patient support services.
  • Partner and engage with healthcare providers.

Technology can enable signal detection. ICSR and real-world data and literature can be used to generate the signal. A tech platform housing all information in one place rather than across disparate, siloed platforms makes it easier for teams — like safety physicians — to keep patients safe.

Automation replaces manual analysis that happens across datasets. The platform can surface different evidence sources contributing to a signal. By linking an ICSR signal (point in time) with tokenised real-world data, the platform can create a longitudinal patient story, eliminate the need to call a provider, and still enable someone to dig into what’s causing a particular reaction to a type of medicine.

This technology can facilitate accurate, timely submission of aggregate safety reports. It can screen literature more thoroughly — and quickly — than teams tasked with screening scientific journals. It’s become far too difficult and expensive to scale enough to accommodate the volumes of available information. An intuitive, intelligent, unified technology platform can surface results from additional subscriptions shared by others conducting similar searches and facilitate information-sharing to help patients.

The pharmaceutical industry is held to strict regulatory compliance standards. Technology helps teams analyse product data across a global product portfolio to determine potential effects from a signal — and act on those signals.

When presented with a product needing multiple submissions to global health authorities, a human team cannot handle the volume without sacrificing speed and accuracy. A tech platform, however, automates many steps in the process, including automatic assignments for someone to review and distribute information to the appropriate affiliates.

Ultimately, the pharmaceutical industry and regulators share a common vision to improve patient safety and outcomes. Technology provides tools for regulators and the industry to collaboratively transform how we deliver patient safety using a patient-centric approach.

Beena Wood
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Beena Wood
11 September, 2023