Bezpieczeństwo farmakoterapii

Podręcznik pharmacovigilance

Have you ever been looking for an answer to the question – what is pharmacovigilance? How is the pharmacovigilance data evaluated? Or how are the risks associated with the use of the medicinal product minimalized during post-marketing surveillance? If the answer is yes, we have a pleasure to propose you a reading of group work entitled “The Safety of the Pharmacotherapy. The Pharmacovigilance Guide”, which answers aforementioned and more questions associated with pharmacovigilance. This book has been scientifically edited by Agata Maciejczyk, PhD Pharm. and Marcin Kruk, PhD Pharm. under the auspices of the Polish Society of Pharmacovigilance (PSPharm). The authors of individuals chapters present thorough practical experience in the field of pharmacovigilance. Let us quote Prof. Edmund Grześkowiak, PhD Pharm. who said: “Presented book is a comprehensive, multidisciplinary study that contains the most up-to-date knowledge in the field of pharmacovigilance. It constitutes a compendium that has been created primarily for the medical community, which is obliged to follow the rules of pharmacovigilance resulting from the Polish law actively. However, it can surely be a valuable source of information for patients and their family members, who comprehend in a modern way the care for their health and widely understood preventive health care.

It is worth to emphasize that adverse drug reaction (ADR) is classified as one of the 10 most important causes of death. Moreover, ADRs are the fifth in frequency reason for hospitalization within the European Union borders. Despite this, only 10% of health care professionals participate actively in the process of reporting adverse drug reactions, which is the source of information essential to assessing the benefit to risk ratio of taking a given medicine. Therefore, education of health care professionals, medical and pharmacy students and other medical faculties, patients, their family members as well as all the others participants of the health care, constitute a necessary element, which may contribute to the increased safety of medicinal products.

Publishing of this book was one of the main objectives for the PSPharm at the point when we started our activity. The ambition of the Society was to create a compendium of knowledge, which would be one of the basic sources of information in pharmacovigilance. While analyzing the finished work and hearing the positive feedback from the readers, we are convinced that the Society goal has been achieved – hence, everyone who contributed to the writing of this book should be thanked! The Management Board of the Society hopes for further cooperation with all the bodies that care about the effective and safe use of medicines.

In order to familiarize yourself with the topics covered in this book, we present a brief content list:

Part I. Monitoring of adverse drug reactions
Adverse drug reactions
Adverse events and adverse drug reactions
Types of adverse drug reactions
Undesirable post-vaccination reactions
Risk populations for adverse drug reactions
Pharmacoeconomics of adverse drug reactions
How a safe drug is made. From clinical trials to the patient
Evaluation of the safety profile during the course of clinical trials. Possibilities and limitations
The registration process of the medicinal product. Registration procedures
Medicinal products subject to additional monitoring
The source of information about the safety of the drug during the post-registration period
Risk management plan
Emergency situations resulting from the drug safety monitoring
The role of physicians, pharmacists, nurses, midwives, and paramedics in the drug safety monitoring
Participants of the adverse drug reaction monitoring system in Poland
Legal obligations of individuals performing the medical profession
Situations requiring special attention
How to report – practical tips
Patient in the adverse drug reaction monitoring system
Reporting of the adverse drug reactions by patients in Poland
The effects of patient inclusion within the adverse drug reaction monitoring system
Obstacles in reporting adverse drug reactions by patients
Actions needed to improve the system
How to submit a report. Practical tips for patients
Sources of information about adverse drug reactions
Alternative sources. The perspective of pharmaceutical companies and drug agencies
Alternative sources. The perspective of others.
Professional literature
Recommended websites
White spots – unverified knowledge
Internet as a source of knowledge on adverse drug reactions
Monitoring of drug safety in regional centers in Poland
Continuous monitoring and evaluation of the pharmacovigilance data
The role of spontaneous monitoring
Continuous monitoring of pharmacovigilance
Causality assessment
Further evaluation of adverse reactions
Transfer of information on the drug safety
Periodic safety report and the expert’s report
Identification of signals
Other methods for pharmacovigilance monitoring
Minimizing the risk after drug registration
Additional drug monitoring
Post-registration studies on drug safety
Post-registration studies on drug efficacy
Educational materials
Pregnancy registers
The quality of the drug and the risk associated with pharmacotherapy
Chief Pharmaceutical Inspectorate as an institution monitoring product quality
The Corhydron case
Cold chain and drug storage
Return of the medicinal product
Fake medicinal products
Patients as a source of risk
Withdrawal of the drug for safety reasons
Drug safety in the European Union
Outline of legal regulations regarding pharmacovigilance in Poland
Guidelines for conducting supervision of the pharmacovigilance
Basic principles under the pharmaceutical law
Reporting of the adverse reactions by patients
Pharmaceutical law and obligations resulting from other legal acts
Pharmaceutical law and monitoring of the safety of dietary supplements and medical devices
Responsibility for monitoring the safety of medicinal products
The power of authorities in proceeding
The mechanisms for supervision – inspection of adverse drug reaction monitoring systems
Quality assurance – basic concepts
Quality and surveillance system on the pharmacovigilance
Audit of adverse drug reaction monitoring system
Inspection of adverse drug reaction monitoring systems
Monitoring of adverse dietary supplements reaction and the safety of their use
The surveillance system on the pharmacovigilance. Standards worthy of imitation

Part II. Drug therapy safety. Examples of cardiological and pediatric pharmacotherapies

Part III. Hospital adverse drug reaction monitoring system in practice

Everyone interested in the book published by MediPage can buy it, among others, on the publisher’s website:

Maciejczyk A., Kruk M. Bezpieczeństwo farmakoterapii. Podręcznik Pharmacovigilance. Warszawa: MediPage; 2017.