Concepts of PV practice
Introduction
As we know, when any new drug is launched into the market, all the information related to its toxicity is made available, resulting in its withdrawal, restrictions in use, etc. Clinical data is collected based on the information shared by the people who participated in controlled clinical trials but rare adverse events may not always be identified in clinical trials because of the lack of long-term safety data and other causes. The risks and benefits of any drug can be better understood only after they are used by a wider group of people and monitored for a longer period.
For this purpose, a Phase IV (Post-marketing surveillance) study is done.
Pharmacovigilance is a multidisciplinary approach that includes the Involvement of many disciplines such as clinicians, pharmacists, nurses, and dentists. But clinicians have a major role in handling ADR, not only for patient safety but also for drug safety monitoring at the population level.
Definition of Pharmacovigilance
Pharmacovigilance is defined as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects(AE) or any other drug-related problem”. It provides oversight of medicines and medical products over their entire lifecycle once they have been licensed and marketed for use.
Pharmacovigilance helps in the following ways as well
Helps to determine if action is needed to improve the safety of a medical product.
It also ensures that healthcare professionals and patients have access to accurate information about medical products or not.
It helps to identify changes in the frequency or severity of known adverse effects.
The roles of pharmacovigilance can be divided into three categories.
1. Surveillance - Support risk management and also assess adverse reaction data to identify patterns.
2. Operations - Collect and record information during preclinical development, and early clinical trials, and gather real-world evidence of adverse events reported by medical professionals and patients after medical products are authorized for commercial use
3. Systems - developed to store and manage data relating to PV compliance at all levels of an organization
Spontaneous Report
A spontaneous report is an unsolicited communication by a healthcare professional (HCP) or consumer to a company, regulatory authority, or other organization (e.g., WHO, Regional Center, Poison Control Center) that describes one or more adverse drug reactions (ADR) in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme.
Adverse drug Reaction
According to the world health organization (WHO), the original definition of adverse drug reaction (ADR) is “a response to a drug that is noxious and unintended and occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease, or for modification of physiological function”.
Pharmacovigilance (PV) Systems and Spontaneous Reporting
PV employs various methods to monitor the safety of Drugs and devices with spontaneous reporting. Spontaneous reporting is the most common one. It is done by people who make a connection between a drug and a suspected drug-induced event. The data about suspected ADRs are collected in a central database. Although spontaneous reporting is critical for drug safety monitoring, under-reporting of ADRs is a limitation of current pharmacovigilance systems. Even though it has inherent limitations, spontaneous reporting provides crucial evidence for generating a hypothesis regarding the association between a drug and an adverse event. Carefully planned post-marketing surveillance and ongoing systematic evaluation using connected databases can help construct efficient PV systems. PV serves as an indicator of clinical care standards that are practiced within a country. Every country has its PV program due to the differences in several factors—including predominant diseases, prescribing practices, the genetic composition of the population, diet, and people’s traditions. These are the factors that can influence the pattern, presentation, and incidence of ADRs.
Fig. Adverse reaction reporting form
Good Pharmacovigilance Practices
Good pharmacovigilance practices also called as GVPs, are guidelines for pharmaceutical companies. These guidelines help them to prevent harm caused to humans by adverse drug reactions (i.e., ADRs) from approved pharmaceutical drugs. GVP applies to marketing-authorization holders, the European Medicines Agency (EMA), and medicines regulatory authorities in EU Member States. They cover medicines that are authorized both centrally via the Agency and at the national level.
The main objectives and roles of GVPs are:
They Promote the safety and effectiveness of pharmaceutical products.
They also promote the delivery of timely information about the safety of medical products.
They help to evaluate observational data on pharmaceuticals, including drugs and medical, excluding blood components.
Also, provide guidance on the conduct of PV for specific product types or populations in which medical products are used.
The European Medicines Agency [EMA] and GVPs
The (EMA) released guidelines for GVPs in 2012. The EMA good PV practices are a set of measures drawn up to facilitate the performance of PV in the European Union (EU). The EMA’s good PV practices are divided into 16 modules, each of which covers 1 major process in PV.
The Food and Drug Administration (FDA) and GVPs
The guidance for good PV practices was issued by FDA in 2005. These are the only guidelines and do not establish legally enforceable responsibilities. Instead, good PV practices guidance describes the FDA’s current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. The FDA’s good PV practices guidance covers medicinal products, including biological and vaccines as well as OTC drugs and devices. The objective of the FDA is to ensure that these Drugs and devices are safe and effective for human use.
Health Canada and GVPs
In 2004, an inspection program for GVPs was implemented by Health Canada. The program is meant to verify that Market Authorization Holders and importers meet the requirements of sections of Canadian Food and Drug Regulations. The program is also to ensure proper tracking of ADR and other post-approval reporting requirements.
Good Pharmacovigilance Practice (GVPs) Compliance
The main objective is that GVPs compliance ensures the safe and effective use of pharmaceutical products by continuously monitoring, collecting, and providing timely information about the safety of medical products to patients, healthcare professionals, and the general public. Regulatory agencies, such as the FDA in the USA, Health Canada in Canada, EMA in European Union, and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, can conduct a GVPs compliance audit at any time in a product’s life cycle (i.e., during a clinical trial, during the regulatory review/approval process, or after a product is on the market).
Conclusion
Pharmacovigilance is an ongoing process during medication use by the patient. It is an essential component of clinical practice that promotes safe medication use through prevention, identification, analysis, management, and documentation of adverse effects (AE)and drug-related problems. Stakeholders involved in PV include patients, healthcare professionals, drug manufacturers, and regulatory agencies (RA). A multidisciplinary approach with HCP such as pharmacists, clinicians, nurses, and dentists is essential for developing an effective PV system. Teaching PV aspects to future HCP as a part of their curriculum will ensure the effective use of these aspects during clinical practice.
References: -
https://www.thefdagroup.com/blog/good-pharmacovigilance-practices-gvp-a-quick-guide
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8219341/#b2-squmj2105-e161-163
https://www.researchgate.net/figure/Adverse-Drug-Reaction-reporting-form_fig4_280246621
https://database.ich.org/sites/default/files/E2D_Guideline.pdf
Student Name: Ankita Kumari
Student ID: 026/022023
Qualification: M. Pharm
E-mail ID: kriankita17@gmail.com
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