Pharmacovigilance Services Provide Patient Safety and Product Value

UBC is committed to delivering safe patient care

Pharmacovigilance Services Provide Patient Safety and Product Value

This week healthcare organizations around the globe have been taking part in Patient Safety Awareness Week by focusing on the importance of healthcare safety. Following the week’s theme, “United in Safety,” UBC recognizes that delivering safe care to patients is an important role for each of us – from frontline staff to the executive suite.

UBC works with manufacturers to ensure the safe use of medicine and medical products – from clinical development to product commercialization and beyond.

My team and I work in pharmacovigilance, which is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or other possible drug-related problems. Pharmacovigilance is usually referred to as drug safety.   

Serious adverse events can result from the use of any medication, either during drug development or during the actual use of approved medications in the real world. In fact, some of the most serious and rare adverse reactions associated with medication use are found only after a drug or biological is marketed and taken by a much larger population of patients than the number taking the medication during clinical development. Drug-induced serious adverse reactions are responsible for 1.5 million US hospitalizations and 100,000 deaths each year. Therefore, this is an area critical to patient safety at each point of a product’s lifecycle. 

While manufacturers readily understand the role these services play in patient safety, they may not fully appreciate the role of pharmacovigilance in providing cost savings through mitigation of unnecessary and costly lawsuits and in maintaining market share by identifying and clarifying potential safety issues that may result in regulatory scrutiny if left uncharacterized.

The value of a pharmacovigilance department is dependent upon a team of highly trained medical professionals, including physicians, nurses, and pharmacists, who:

  • Have had clinical experience in patient care
  • Can perform high-quality medical evaluation of reports of serious adverse experiences
  • Can understand the implications of reporting these events to the global regulators (e.g., Food and Drug Administration, European Medicines Agency etc.). 

In my 20+ years of experience in the industry, I’ve seen pharmacovigilance teams challenged by a lack of experienced staff. While budgets often allow for technology investments, many don’t allow adequate resources for a well-rounded staff that includes nurses, pharmacists, and physicians with real-life clinical experience.

Regulatory agencies are increasingly demanding high-quality medical evaluation of adverse events reported in association with marketed medications that only staff with the necessary clinical and regulatory experience can provide. This expertise is needed to identify drug event combinations, evaluate potential safety issues, and expedite reporting from a regulatory perspective. Data mining is a necessary component of identification of safety signals, but it only reveals signals of disproportionate reporting and cannot be used in determining actual causality of a drug with regard to a specific serious adverse event. Only high-quality medical evaluation of the information provided in Individual Case Safety Reports can determine the likelihood of whether a specific drug has or has not caused a specific adverse event. UBC has assembled a team of medical professionals that is highly skilled in the performance of pharmacovigilance activities, both during clinical development and throughout the postmarketing lifecycle of pharmaceuticals.

Are you looking for a service provider with a medically qualified pharmacovigilance team? Contact me to discuss how UBC can help deliver safe patient care while also delivering value to your organization.