THE ROLE OF PHARMACOVIGILANCE IN DRUG SAFETY MONITORING
THE ROLE OF PHARMACOVIGILANCE IN DRUG SAFETY MONITORING
INTRODUCTION
• The World Health Organization defines pharmacovigilance (PV) as “It is a pharmacological science which deals with safety of medications and activity which concern to assess, detect, understand and prevent adverse effects or adverse drug reactions.
• Pharmacovigilance may be a process of perpetual monitoring and evaluation of all adverse events during the pharmaceutical development process, to make sure of the security of the parties and a continuing assessment of the risk and the benefit.
• The majority of safety information is considered before post-marketing surveillance from controlled clinical test.
• The clinical test process is regulated by ICH GCP, USFDA guidelines etc.
• Pharmacovigilance, also applied to as pharmaceutical safety, is the knowledge of understanding the adverse effects caused by a medicinal product and assessing whether the benefit will outweigh the risk.
• This includes discovery of adverse effects during the clinical trial and post-market surveillance, monitoring and upgrading the risk- benefit proportion based on relative findings, preventing or minimization of adverse effects and most significantly, harmonized communication of these results to the affected global regulatory authorities in a timely manner.
ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
• Sponsors, typically pharmaceutical companies, are obliged to develop the clinical trial protocol.
• The protocol marks out every aspect of the study, by taking consideration the explanation for the trial, designs, trial population with evolved exclusion and inclusion criteria, experimental drug administration, trial procedures, data collection principles, endpoints and sample size.
• The protocol too details the safety reporting procedures, especially on the demand for accelerated reporting of serious adverse events.
• The Informed Consent Form is used to reveal current information about investigational medicine and about the procedures, risks and benefits for subjects who share in the clinical trial.
• With access to all the accumulating data, sponsors are authorized to report crucial safety information to all stakeholders in a timely fashion.
2. Subjects:
• Subjects are patients or healthy volunteers who agree to participate in a clinical trial and have signed the Informed Consent Form.
• The informed consent must be given freely, without compulsion and must be based on a clear-cut understanding of what participation concern involves.
• By giving consent, subjects give permission to the investigators to collect health information and body measurements as per the protocol.
• While by encouraging the subjects to follow the protocol until trial completion takes place, subjects can withdraw at any time. The reason for withdrawing the consent is not necessary by the subjects.
3. Investigators:
• Investigators are qualified individuals who are skilled and experienced to give medical care to subjects registered in the trial.
• While the trial is ongoing, investigators are supposed to follow up with the protocol treatment plan in delivering care.
• They observe, evaluate, measure, negotiate and document all effects of treatment, including the reporting of adverse events.
• They are responsible for informing their institutional review boards and the sponsor of any issues that pose a threat to the safety and wellbeing of the trial subjects.
• Investigators are eventually accountable and responsible for the conduct of the clinical trial and for the safety of the subjects under their care.
4. Institutional review board/ Ethics committee:
• The Institutional Review Board (IRB), also well known as the ethics committee, is charged with protecting the rights and welfare of human subjects enlisted to participate in research protocols conducted under the endorsement of the institution to which the IRB is affiliated.
• The IRB reviews all clinical trial protocols concerning human subjects that the particular institution is involved with and has the authority to approve, disapprove or require modifications to the protocols.
• IRBs have the further responsibility of reviewing ongoing research to ensure continued diligence that subjects are not placed at undue risk and they give unforced, informed consent to the subjects.
5. Data and safety monitoring board:
• The Data and Safety Monitoring Board (DSMB), also known as the data monitoring committee (DMC), is an expert panel, independent of the sponsor, chartered for one or other clinical trials.
• The authorization of the DSMB is to review on a regular basis the collected data from the clinical trial to secure the continuing safety of current parties and those yet to be registered.
• The DSMB may review effectiveness data as pre- defined in the meantime to assess whether there’s inviting confirmation of effectiveness or the lack thereof, so that the clinical equilibrium at the launch of the trial is not justified.
6. Regulatory authorities:
• In the US, preceding to the initiation of a first human clinical trial, pharmaceutical sponsors submit an Investigational New Drug (IND) application to the FDA as required by law.
• In 2010, the FDA issued guidance to sponsors and investigators on safety reporting necessary for human drug and biological products that are being investigated under an IND and for drugs that are the subjects of bioavailability (BA) and bioequivalence (BE) studies that are free from the IND requirements. The guidance stipulated the agency’s expectations for timely review, evaluation and submission of relevant and useful safety information and implemented internationally harmonized definitions and reporting standards.
• Pharmacovigilance in drug monitoring
A new drug must pass three barriers before its approval by the national drug regulatory authority.
Sufficient documentation is needed to show the new medicine is
• good quality,
• Effective, and
• Safety
Whereas the first two criteria must be met before any consideration can be given to drug approval, the issue of safety is less certain.
Safety isn't absolute, and it can be judged only in relation to effectiveness, taking discernment on the part of the controls in deciding on adequate limits of safety.
There are other aspects of medicine safety that have been rather neglected until now, which should be included in monitoring inert and long-term effects of medications. These include
•Discovery of pharmaceutical interactions.•Measuring the environmental burden of drugs used in large populations.•Assessing the alms of inactive constituents (excipients) to the safety profile.•Systems for comparing safety biographies of analogous drugs.
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