Pharmacovigilance

The Importance of Pharmacovigilance in the Medical Industry

The practice of pharmacovigilance is a relatively young science relating to the study and outcomes of a variety of prescription and over the counter drugs that are available to the public. In 1961, the respected World Health Organization (WHO) established a program to keep the public safe from disaster due to the harmful side effects of drugs. This was in response to the birth defects caused by the sleeping pill thalidomide, which had been labeled as safe for pregnant women.

Since the establishment of pharmacovigilance, doctors, scientists and consumers have contributed to gathering information regarding various medications, even drugs that are seemingly benign, like first aid ointments. The data that has been gathered is made available to the medical industry and consumers so that they can understand the potential for side effects from medicine.

Pharmaceutical companies take the reports of adverse effects seriously, and their scientists do aggressive follow up on the reports to ensure consumer safety. They also complete risk evaluation mitigation strategies to determine the severity of the side effects. Drug safety and drug interactions are the primary goals of pharmacovigilance.

The ability to gather the necessary data regarding drug-related issues is important in keeping the public safe. It’s important for consumers to read the safety data on their medications to understand the potential for risk and any possible drug interactions with other pharmaceuticals. 

Pharmacovigilance is at the forefront of consumer safety and is responsible for taking a proactive approach to drug safety issues and potential adverse effects. Although pharmaceutical companies benefit tremendously from using pharmacovigilance services, it is ultimately beneficial for the health and well-being of everyone.

The Importance of Pharmacovigilance: Safety Monitoring of medicinal products, WHO 2002.

2 World Health Organization. Essential medicines and health products Pharmacovigilance. [Internet]. 2015 [cited 01 Oct 2019]. Available from:

https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/

3 World Health Organization. Fast Facts on Pharmacovigilance. [Internet]. 2015 [cited 01 Oct 2019]. Available from: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/PV_fast_facts/en/

With years of experience delivering regulatory support for our clients’ pharmacovigilance needs, our highly qualified team of safety professionals adheres to good pharmacovigilance practices with timely regulatory screening and reporting of adverse events and product complaints. Language capabilities include English, French, German, Portuguese and Spanish.

  • Complete initial screening for adverse events and product complaints
  • Prepare case narratives of Individual Case Safety Reports (ICSRs) from clinical trial and postmarketing sources
  • Provide detailed and systematic follow-up for all cases
  • Enter data into client’s safety database including:

    Evaluation of serious criteria

    Coding using MedDRA, WHO Drug, Company Drug Dictionary

    Expedited submission of ICSRs

  • Conduct medical review of cases
  • Conduct quality control activities
  • Conduct quality assurance activities
  • Detect, track, investigate, and evaluate signals and risk-benefit of product

  • Prepare regulatory safety reports (eg, PADERs, PSURs, PBRERs)

  • Conduct systematic review of medical literature

  • Provide metric reports on compliance, quality, and other key performance indicators

  • Write/revise standard operating procedures based on good pharmacovigilance practices

  • Provide support for Risk Management Plans (RMPS) and Risk Evaluation Mitigation Strategies (REMS)

  • Include comprehensive MedDRA upgrades, in both English and Japanese, utilizing BKP Technologies’ BKP Codex Up-Versioning tool

  • Conduct audit inspection/readiness

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