The Importance of Pharmacovigilance in Modern Healthcare
Pharmacovigilance is an entirely scientific and process-driven area within pharma that describes the safety of medicines and taking action to reduce the risks and increase the benefits of drugs and therapies. It is concerned with two outcomes of drugs: safety and efficacy. It is one of the most fundamental functions within a life science company that mostly touches every aspect of the drug lifecycle – from preclinical development to post-market surveillance. Let’s delve into the importance of pharmacovigilance, the need for pharmacovigilance now, and its role in the future within this blog.
Why did Pharmacovigilance come into existence?
The prevention and treatment of diseases have undoubtedly been transformed with the help of medicines and vaccines. However, medicinal products may also have undesirable and/or unexpected side effects in addition to their benefits. The unfortunate incidents in history, with deaths caused by anesthesia and congenital malformations from thalidomide use, have evolved the need for safety monitoring. This compelled the need for science to detect, assess, understand and prevent adverse effects or any other medicine/vaccine-related problem. This branch of science has been termed as Pharmacovigilance.
Effect of pharmacovigilance on Adverse Events and Adverse Drug Reactions
An adverse event is any reaction or side effect within a patient’s body caused by a drug molecule. A severe adverse drug reaction is life-threatening and causes hospitalization, incapacity, permanent damage or, in extreme cases, the death of a patient. All clinical research investigators must report adverse events, even if the side effects are only suspected. Pharmacovigilance determines which adverse events cross the line of a drug’s efficacy. In other words, it is essential to analyze which side effects of a drug can lead to higher risk in patients compared to its effectiveness in treating a disease. For instance, chemotherapy is known to cause some severe side effects. Still, when compared with life-threatening cancer, these side effects are considered acceptable, given the potential to cure a patient. However, the risk to the patient would be considered too great, and the benefit not substantial enough to justify the potential damage if a drug used to cure a headache caused similar side effects.
A global database is maintained by collecting the reports from adverse drug reactions (ADRs) that can be used to evaluate the associations between various medications and associated ADRs. Rigorous testing of all medicines and vaccines is done through clinical trials for safety and efficacy before they are authorized. However, the clinical trial process involves studying these products in a relatively small number of selected individuals for a short period. Specific side effects may emerge when these products are used by people with other concurrent diseases over a long period.
Understanding the Role of Clinicians in Pharmacovigilance
A crucial role is played by clinicians in preventing ADRs by recognizing, managing, and reporting ADRs to the national pharmacovigilance centers (NPCs). Factors such as age, medication error, polypharmacy, and patient-specific risk factors, such as comorbidities, may increase the risk of ADRs. Thus, therapeutic reasoning and appropriate drug selection for each patient lead to safe and rational drug prescriptions.
Clinicians are required to know the clinical pharmacological principles of ADRs, including their types, dose-relatedness, hypersensitivity reactions, time relationships, and risk factors, to recognize ADRs and differentiate them from other diseases or comorbidities.
Main areas of pharmacovigilance
Pharmacovigilance can be broadly divided into four main sub-specialisms, although it is a vast and encompassing discipline.
Operations:
Professionals interested in drug safety jobs generally begin their careers in this sector. Drug safety operations typically include case processors, drug safety officers/associate and drug safety managers, team leaders, and directorships. In addition to gathering objective world evidence (RWE) of adverse events reported by doctors and patients post-market, these professionals will collect and record information during preclinical development and clinical trials. Operations are also usually responsible for creating individual case study reports, standard operating procedures (SOPs), literature screening and regulatory expedited reporting.
Surveillance:
Professionals in this area look towards risk management and signal detection jobs. This involves performing an analysis of the data collated by the broader division. Professionals in this area can hold an array of titles, the most common of which are pharmacovigilance scientist and drug safety physician. Still, like in all teams, many degrees of seniority and remit are available. These professionals analyze the drug safety information gathered by the more comprehensive department and assist with creating and reviewing aggregate reports. They also create development safety update reports (DSURs) for drugs in clinical research and periodic benefit-risk evaluation reports (PBRER) for post-market drugs. These reports ultimately help the team to conclude the safety and efficacy of a drug or candidate molecule.
Systems:
This division is concerned with the building and ongoing development of a fully robust and innovative system charged with housing and allowing access (in various forms) to vast quantities of safety data. This safety data is usually collated by those working in operationally focused roles but is accessed by all. The systems division must constantly improve and stay in line with changing regulations and requirements for the business/ health authorities, making this a very challenging and vital aspect of drug safety.
Qualified Person for Pharmacovigilance (QPPV)
QPPVs’ jobs are mainly concerned with marketed drugs and those about to be authorised. Still, as QPPVs are considered by many to be subject matter experts, their expertise is utilised across the discipline and broader business. Very experienced professionals play the role of senior pharmacovigilance officers, focusing on understanding, planning for, and advising upon the regulations and requirements that companies must adhere to. This is a highly strategic appointment and one of great importance.
Conclusion
The Graduate Drug Safety and Pharmacovigilance Certificate Course at Sollers College offers cohesive job-oriented training in the drug development process and drug market lifecycle. Our drug safety certification covers the basics and the intricacies, from drug safety protocols and adverse reporting to risk management and regulatory requirements. Each candidate is taught the understanding of ADRs, adverse events, and safety-focused issues from the FDA, IMA, and other renowned global agencies through our pharmacovigilance courses. Join Sollers College for extensive hands-on training and expert-led workshops to enhance your career prospects with the best pharmacovigilance and drug safety certification.
Fortunately, several pharmacovigilance jobs are available for drug safety professionals due to the different types of companies within life sciences, including global pharma, small pharma, generics companies, drug safety consultancies, and health authorities. Each offers slightly different opportunities, but in every case, there is plenty of scope for professionals to progress in their pharmacovigilance careers.
