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Conclusion
Chapter 5
Conclusion As the title of this book suggests pharmacoepidemiology and pharmacovigilance work in synergy to allow for a better assessment and/or management of adverse drug reactions. Not too long ago, the clinical evaluation of drugs was mainly based on the results from randomized, controlled clinical trials; however, as we have shown in this book, the conclusions from clinical trials are limited to the patients enrolled in the trials. While the internal validity of these studies can be high, the external validity is not always representative of the drug’s experience once used in the real world (i.e., uncontrolled settings). It has become increasingly necessary to complement data from experimental clinical trials data obtained in the real world of use of drugs in clinical practice (outside the context of clinical trials), i.e., throughout the entire life cycle of a product. Pharmacovigilance is essentially based on the qualitative and quantitative study of spontaneous adverse drug reactions reports, followed by a clinical assessment/judgment with regards to its impact on the overall safety profile of the drug. It is particularly useful for identifying potential safety signals of a rare adverse event or in orphan disease settings where exposure data are limited prior to marketing. The purpose of pharmacovigilance is to enhance patient care and patient safety in relation to the use of medicines according to the life cycle of a health product. Furthermore, pharmacovigilance can support public health programs by providing ongoing data throughout a product’s life cycle allowing for an accurate, reliable, and balanced assessment of the riskebenefit ratio of the product as more and more data becomes available with its use in the market. Pharmacoepidemiology is best described as the study of drug use in real-world conditions in large populations to assess the effectiveness and risks associated with the use of a health product. Pharmacoepidemiology allows for the characterization of the conditions of use, misuse, clinical effectiveness, adverse drug reactions, and risks of drugs. The development of pharmacoepidemiology has allowed for a better optimization of drug uses. By studying larger populations in real-world settings, along with establishing reasonable comparable groups, pharmacoepidemiology studies allow for the quantification of risks that is impossible to carry out using spontaneous reporting alone. It also enables the highlighting and quantification of safety signals for events that are frequent and multifactorial, where the role of a drug in individual cases can be difficult to detect. Pharmacoepidemiology and Pharmacovigilance. https://doi.org/10.1016/B978-0-12-816183-8.00005-6 Copyright © 2019 Elsevier Inc. All rights reserved.
137
138 Pharmacoepidemiology and Pharmacovigilance
Considering what it is mentioned in this book, we can confirm that the scientific disciplines of pharmacovigilance and pharmacoepidemiology truly complement one another and can be applied together to enhance drug safety, but in no way can one replace the other.
Conclusion As the title of this book suggests pharmacoepidemiology and pharmacovigilance work in synergy to allow for a better assessment and/or management of adverse drug reactions. Not too long ago, the clinical evaluation of drugs was mainly based on the results from randomized, controlled clinical trials; however, as we have shown in this book, the conclusions from clinical trials are limited to the patients enrolled in the trials. While the internal validity of these studies can be high, the external validity is not always representative of the drug’s experience once used in the real world (i.e., uncontrolled settings). It has become increasingly necessary to complement data from experimental clinical trials data obtained in the real world of use of drugs in clinical practice (outside the context of clinical trials), i.e., throughout the entire life cycle of a product. Pharmacovigilance is essentially based on the qualitative and quantitative study of spontaneous adverse drug reactions reports, followed by a clinical assessment/judgment with regards to its impact on the overall safety profile of the drug. It is particularly useful for identifying potential safety signals of a rare adverse event or in orphan disease settings where exposure data are limited prior to marketing. The purpose of pharmacovigilance is to enhance patient care and patient safety in relation to the use of medicines according to the life cycle of a health product. Furthermore, pharmacovigilance can support public health programs by providing ongoing data throughout a product’s life cycle allowing for an accurate, reliable, and balanced assessment of the riskebenefit ratio of the product as more and more data becomes available with its use in the market. Pharmacoepidemiology is best described as the study of drug use in real-world conditions in large populations to assess the effectiveness and risks associated with the use of a health product. Pharmacoepidemiology allows for the characterization of the conditions of use, misuse, clinical effectiveness, adverse drug reactions, and risks of drugs. The development of pharmacoepidemiology has allowed for a better optimization of drug uses. By studying larger populations in real-world settings, along with establishing reasonable comparable groups, pharmacoepidemiology studies allow for the quantification of risks that is impossible to carry out using spontaneous reporting alone. It also enables the highlighting and quantification of safety signals for events that are frequent and multifactorial, where the role of a drug in individual cases can be difficult to detect. Pharmacoepidemiology and Pharmacovigilance. https://doi.org/10.1016/B978-0-12-816183-8.00005-6 Copyright © 2019 Elsevier Inc. All rights reserved.
137
138 Pharmacoepidemiology and Pharmacovigilance
Considering what it is mentioned in this book, we can confirm that the scientific disciplines of pharmacovigilance and pharmacoepidemiology truly complement one another and can be applied together to enhance drug safety, but in no way can one replace the other.