The Impact and Importance of Pharmacovigilance

importance of pharmacovigilance

Do you think there’s something more crucial than a patient’s safety? As a health care provider, your patient safety is your priority. Performing a risk-benefit assessment for every patient, before any intervention or treatment decision, is pivotal to keep your patient safe. Therefore, any science or activity that strengthens this concept is of great importance. And here, we can discuss the importance of pharmacovigilance.  

What is Pharmacovigilance?

The pharmacovigilance scope is broad-ranging. It is covering drug interactions, medication errors, lack of drug efficacy, unauthorized medications, irrational use of medicines, acute and chronic poisoning, case reports, drug-related mortality, and anything related to adverse drug reactions. [1] 

 The WHO defined Pharmacovigilance: “The science and activity relating to the detection, assessment, and prevention of adverse effects or any other drug-related problem.[2] 

But if you think that pharmacovigilance is just a science dealing with medications’ safety, you’re mistaken. Herbs, biological products, vaccines, blood products, and medical devices’ safety are present under the umbrella of pharmacovigilance. Also, providing training programs to health care providers and keeping them communicated are from the responsibilities of pharmacovigilance. And because the roles of pharmacovigilance are expanding through the past decades, you can predict more roles in this enormous system. [1]


The Impact of Pharmacovigilance on Adverse Drug Reactions

In 1994, more than 100,000 deaths occurred because of adverse drug reactions. And in the period between 1999 and 2008, the adverse drug reactions were responsible for 26,399 deaths and 0.9% of the emergency hospital admissions, which means that adverse drug reactions are responsible for increasing the patients’ morbidity and mortality worldwide. [4]  

To overcome this phenomenon, the pharmacovigilance directed its efforts to manage the drug adverse effects through its international central database, which collects the adverse effects of drug reports from all the countries worldwide. This role has a significant impact on improving the medicines’ safety profile, enhancing patient care and safety, and also supporting the work of national drug regulatory authorities. [5]


And now, let us have a broad discussion on the importance and impact of pharmacovigilance.

Read also: Historical Overview of Pharmacovigilance

The importance of Pharmacovigilance in Clinical Trial Regulation

During the past few years, we have shown a significant increase in the number of clinical trials, and this phenomenon is a double-edged weapon!

Although new medicine development is crucial for a large portion of patients, the random increase in the number of clinical trials may affect the function of ethics committees and regulators, which may lead to unethical patient practices, poor reporting of adverse effects, and poor patient monitoring during the phases of clinical trials. [1]

To overcome these challenges the pharmacovigilance took part in the clinical trial regulation to guarantee proper monitoring, reporting, and assessment of clinical data. The CIOMS (Council for International Organization of Medical Sciences) working groups on pharmacovigilance have the same roles, besides standardizing and coordinating the adverse drug reporting process internationally between the pharmaceutical manufacturers and the regulatory authorities. [6]

The Importance of Pharmacovigilance in the Post-Marketing Saftey Monitoring

About 10% of the newly-approved drugs are withdrawn from the market after their release. Introducing a new medicine to the market after its approval does not guarantee its safety. Premarket studies can not determine the complete drug safety profile. Small sample size, short study duration, and also excluding some patients’ categories, like the elderly and children, may affect the drug safety profile results. Besides, the pharmaceutical companies exert more effort to prove the drug efficacy rather than its safety. [3]

Also, the utilization of a particular drug for several years for a large portion of patients does not confirm its safety. Vioxx (Rofecoxib) was approved by the FDA in 1999 and withdrawn from the market in 2004. Vioxx proved its efficacy as a non-steroidal anti-inflammatory drug with a lower risk of gastrointestinal bleeding; however, it caused serious cardiovascular events for thousands of Americans during these years. [7]

Therefore, the role of pharmacovigilance in the drug safety monitoring for any adverse drug events is necessary either for the new medicines or the old one. And here, the health care providers and the community have a vital role in reporting any adverse drug events to support the role of pharmacovigilance. [3]

The Role of Pharmacovigilance in Monitoring of Herbal and Traditional Medicines

Why should we monitor the use of herbs? It comes from nature, which means it’s completely safe! This is a common wrong concept among a high percentage of people. Herbal products may be adulterated with dangerous substances, which can have serious effects on the consumer. Also, some herbs interact with particular drugs, resulting in an unwanted increase or decrease in drug concentration.

Therefore, the National Pharmacovigilance included the herbal and traditional medicines in its programs to monitor their safety. [1]

The Importance of Vaccine Pharmacovigilance       

Most people believe that any vaccine is safe, so any change in this belief will lead to serious outcomes. Vaccine’s safety should be monitored to guarantee public compliance with the vaccine programs. [1] Here the concept of vaccine pharmacovigilance arises: “ It is the science and activities relating to the detection, assessment, understanding, prevention, and communication of adverse events following immunization, or any other vaccine- or immunization-related issues.” [8]

The Importance of National Pharmacovigilance centers in Educating and Training the Health Care Providers

Nobody can deny the importance of health care providers in supporting the role of pharmacovigilance worldwide. For proper recognition of the adverse drug event, the health care provider should have high levels of awareness.

National Pharmacovigilance Centers have vital roles in training the health care team to diagnose and report any adverse drug events. [1] These centers are approved by the WHO, including countries in the WHO Program for International Drug Monitoring. The community and health care providers can report any adverse drug event to their National Pharmacovigilance Center. [9] 


What we can conclude, The importance and roles of pharmacovigilance are significant; they are increasing and expanding throughout the years to include various disciplines related to patient safety. And the participation of the community and health care providers is crucial to reach the best results. 

Written By: Sara Ahmed Zaki

 References:

  1. http://archives.who.int/tbs/safety/s4893e.pdf 23/9/2020
  2. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/ 23/9/2020
  3. https://www.longdom.org/open-access/importance-of-pharmacovigilance-and-the-role-of-healthcareprofessionals-2329-6887-1000252.pdf 23/9/2020
  4. https://academic.oup.com/ajhp/article-abstract/74/8/606/5103382?redirectedFrom=fulltext 23/9/2020
  5. https://www.globalpharmatek.com/blog/importance-of-pharmacovigilance/ 
  6. https://cioms.ch/pharmacovigilance/. 23/9/2020
  7. https://www.medscape.com/viewarticle/490355 23/9/2020
  8. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2907013/. 23/9/2020
  9. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/nat_centres/en/ 23/9/2020





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