Why Should Pharma Companies Encourage Healthcare Professionals to Report Adverse Events?

by Teresa Resia Esposito Senior Pharmacovigilance & Quality Assurance Consultant - @PQE Group

Healthcare professionals are valuable allies for pharmaceutical companies, striving to monitor the safety profile of their drugs and to promote their products’ safe and effective use. Good pharmacovigilance practice of pharmaceutical companies have the power to build trust and confidence among patients when using their medicinal products.

Moreover, consistent and robust safety data collected in the post marketing phase can dispel myths and rumors about adverse drug reactions (ADRs) to medicines.

For this reason, it is fundamental for pharma companies to share the culture of reporting among healthcare professionals who are the major providers of spontaneous reports of ADRs 

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Pharmacovigilance Systems in Pharma Companies 

Pharmacovigilance is defined as the "science and activities relating to the detection, assessment, understanding, and prevention of adverse events or any other medicine-related problem." Pharmaceutical companies, as Marketing Authorization Holders, have specific obligations in this regard, defined by their respective legal framework. In particular, they must have a pharmacovigilance system suitable for collecting information on medicinal products and designed to monitor the safety of authorized medicinal products and detect any changes to their risk-benefit balance. In addition to a regulatory requirement, a good pharmacovigilance system represents a fundamental strategy to ensure patient safety, improve the company's reputation, and guide the development of increasingly safe and effective therapies. 

Post- Marketing Pharmacovigilance 

The safety profile of a medicinal product available on the market must be constantly monitored because the population it comes into contact with is much more complex than the limited sample of patients undergoing pre-marketing clinical trials. New variables come into play, such as pre-existing diseases, drug interactions in multi-drug therapy, genetic and dietary factors, special groups (pregnant women, children, elderly) and the duration of treatments (e.g., chronic use), which can bring forth new safety and efficacy information (e.g., rare but serious adverse reactions, potential risks, etc.). 

Economic Considerations 

One important piece of information coming from this research is that QbD has been practiced more in small molecule realities than in biotech, which can be explained by the intrinsic complexity of the various steps of a biotech product. It has also been evidenced that most QbD-developed biotech products have used this approach during drug substance development, a critical and complex phase that includes steps such as the development of master and working cell banks, and the manufacturing process and its scale-up. 

Another major concern from pharma companies in general comes from the cost of the activities, mainly because the investment should be done in an early phase of the project, when still it is unknown if the target product would really be fit for the market and when no data from clinical studies are available yet. 

Some uncertainty and misunderstanding regarding the definition of the pillar of QbD could be the source of difficulties in applying this approach, especially in the first years in EU. Finally the regulatory benefits are unclear. 

One certain benefit in applying the rule of building quality into the product would be avoiding showstoppers when the project will be in an advanced status due to the use of materials, potentially affecting the quality of the final product. 

Spontaneous Reports

In the history of pharmacovigilance, healthcare professionals (HCP) have been the major providers of case reports of suspected ADRs. However, underreporting of ADRs remains a major problem. To overcome this deficiency and have a reasonable amount of safety data, pharmaceutical companies should contribute in spreading the culture of reporting among healthcare professionals. This should emphasize the value of pharmacovigilance as an integral part of clinical practices and promote growing awareness of the industry’s fundamental role in improving the understanding of diseases and the safer use of medicines.   

 

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The Central Role of Healthcare Professionals in Pharmacovigilance 

In the collective imagination, the healthcare professional is the reference figure we turn to when we have a health problem. Healthcare professionals represent much more in clinical practice as they are the connecting figure between pharmaceutical companies, national pharmacovigilance centers, and patients. They play a key role in preserving public health, which is among the objectives of pharmacovigilance. Furthermore, they possess the right knowledge, skills, and readiness to identify, recognize, manage, and prevent adverse drug reactions.

 

 

Sources: 

  1. World Health Organization (WHO). The importance of pharmacovigilance: safety monitoring of medicinal products. Genève: WHO; 2002 
  2. World Health Organization (WHO). The safety of medicines in public health programmes: pharmacovigilance an essential tool. Genève: WHO; 2006 

 

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