July 19, 2019
In Pharmacovigilance we trust: Part 2
By: Ross Wooddisse

In a recent blog post, I shared some of the key outputs from the recent Accenture Pharmacovigilance (PV) Industry Leaders’ Roundtable meetings with our Life Sciences clients, where we focused on the challenge of becoming a patient-centric PV organization, and renewing the trust between patients and the pharmaceutical industry throughout the patient journey. In this blog, I’ll continue to explore through a patient scenario, demonstrating the impact that PV can have on a patient’s experience.

Supporting the Clinical Study Journey
Imagine how PV can influence the healthcare journey of a single patient involved in a clinical study at a critical and worrying moment in her life.

Let’s consider Pat1, a middle-aged woman who lives with her husband and their teenage son. She has been a primary school teacher for 20 years and loves the energy she gets from teaching children. Pat is health conscious, packing her own healthy lunches and exercising by walking around the block during breaks. She wears a smart watch and enjoys tracking her cardiovascular activity and exercise.

However, one year ago, Pat was diagnosed with locally advanced breast cancer. Since surgery, she has been on combination treatment with adjuvant chemotherapy and radiotherapy. She finds that the treatments and hospital visits are draining her energy. A colleague recommends that Pat may want to look at experimental treatments available in upcoming clinical studies.

Following a monthly check-in with her doctor, Pat completes an online questionnaire for a clinical research study. She learns she may be eligible and looks into how to enroll.

Pat feels hope, tinged with anxiety
As Pat gets learns more about the clinical study, she has high hopes for success. Knowing that gathering information about her treatment could contribute to the body of evidence on safety, quality and efficacy that will potentially allow the drug to be marketed for the benefit of many, Pat feels good about the chance to help others as well as herself.

As Pat moves forward on her journey, she has a number of worries, for example:

  • What if am not accepted into the study and can’t get access to the experimental treatment?
  • What if I do participate and the side effects are awful?
  • Will I be taken off the study if I raise adverse events?
  • Might this treatment be my last hope, and could it fail?

Pat’s anxiety is common. However, the way PV professionals communicate safety information can proactively reduce Pat’s anxiety. For example, PV can help to:

  • Ensure honesty and clarity about what the study is—and is not;
  • Ensure safety and risk, and potential benefit, are explained in a balanced way, communicating information relating to the study treatment, protocol and treatment safety in an easy to understand manner;
  • Make information available digitally so that it can be referred to at any time—in addition to visits or handouts—and it is immediately up to date if there any changes; and
  • Provide answers about safety that may be of individual relevance to the participant, considering risks and mitigations that are tailored to the individual’s circumstances if appropriate.

Drug safety pivots towards the patient
One test of PV’s trust-building potential can arise following a serious and unexpected suspected adverse reaction, or during the unfolding of a broad safety concern. This is when the advocates of patient safety—the pharmacovigilance leadership and the scientific/medical experts within the PV teams—jump into action to assess the individual case relatedness and overall product adverse event causality, the safety risks, and put in place measures that will protect current and future patients.

Sometimes this requires difficult decisions about the continuation of studies or putting urgent safety risk minimization measures in place to support the favorable benefit-risk profile. Adverse events can be serious (including life threatening) and, very rarely, patients like Pat may be unexpectedly harmed by an adverse event. PV professionals are always conscious of the hazards and of the potential harms of safety risks and focus on managing those risks optimally.

Patient stories help pharmacovigilance shape new role
The story of Pat and thousands of patients just like her show how PV can utilize its role appropriately to contribute to increasing patient trust and add to industry value. Considering Pat’s journey itself helps PV leaders understand and engender the ”trust equation” and take proactive measures to inform patients and potentially progressively change perceptions.

Like most patients, Pat is concerned with safety events and worries about what happens if something goes seriously wrong. She needs to know that safety events are the top priority for everyone in healthcare—from clinical studies to clinical practice. When they occur, it is “all hands-on deck” to ensure emerging risks are handled appropriately and with suitable urgency. Strong safety governance is essential at this critical time, as the necessary interventions are debated, agreed and actioned in a timely fashion and with the highest quality.

During the PV Industry Leaders’ Roundtable, we discussed the potential perceived differences in priorities between patients and the industry and considered potential solutions for improved alignment. The general understanding by the patient—and even by healthcare professionals—about the importance and role of PV can be limited. Therefore, the level of PV education should be increased.

If you would like to learn more about Accenture’s PV services and platform, or if you are interested in joining a future Pharmacovigilance Industry Leaders’ Roundtable, please contact me.

1Fictional character

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