Introduction: It is well known that prescription drugs can result in a myriad of ADRs, including psychiatric ADRs. Psychiatric effects of drugs can impact sensorium, attention, concentration, memory, and higher cognitive functions resulting in distressing physical illness and psychiatric consultation. Generally, in regards to psychiatric effects associated with drug therapy, complications such as depression and suicidality (suicidal thinking and behaviour) are those most frequently reported. Prescription drugs with known psychiatric ADRs include steroids, antibiotics, hor-monal drugs, acne drugs, attention-deficit hyperactivity disorder (ADHD) drugs, anti-depressants, anti-parkinsonians, anti-convulsants, antima-larials, antihypertensives, antihistamines, sedatives tranquilizers, statins, and anti-smoking agents.

Objective and Methodology: To review the SmPCs and literature of antihypertensive drugs prescribed commonly in medical practice and under-stand the common, uncommon, rare, very rare psychiatric ADRs and risks associated with these drugs. A list of the most common antihyperten-sives prescribed in medical practice was prepared and categorized according to the mechanism of action. The most recent SmPCs of the selected drugs from the MHRA website were retrieved, and Section 4.8 Undesirable effects were reviewed. Drugs from various treatment categories were included for this analysis: Angiotensin Receptor Blockers (ARBs), ACE Inhibitors; Beta Blockers; Anti arrhythmia drugs; Calcium Channel Blockers (CCB); Centrally acting drugs and Vasodilators.

Results: The analysis involved reviewing of the SmPCs and literature for common, uncommon, rare and very rare psychiatric ADRs based on the Psychiatric System Organ Class (SOC) effects per MedDRA Preferred Terms (PTs) ranked under headings of frequency. Almost all the drugs from each category reported psychiatric ADRs ranging from common to very rare listed in the SmPCs. Depression, depressed mood, anxiety, nervousness were common for the Alpha and Beta-blocker group, which are the most prescribed drugs in patients with hypertension. Insomnia, sleep disturbances, confusion, psychosis were uncommon in all drug treatment categories, while hallucinations, mental confusion, disturbance in attention, depression, and personality disorders were rare and very rare ADRs. None of the drug categories listed suicidality or suicide attempt as an ADR.

Conclusion: Identification of psychiatric ADRs related to drug therapy in real-world post-marketing setting is difficult. Reporting rates deter-mined on the basis of spontaneously reported post-marketing ADRs are generally presumed to underestimate the risks associated with drug treatment. As a medical student, this exercise will help me to assess patients starting therapy with antihypertensives, identify and report ADRs to the MHRA, monitor ongoing ADRs, and lastly, read the SmPC as guidance to good medical practice.

For pharmaceutical companies, establishing a solid pharmacovigilance (PV) system is mandatory, and when mergers and acquisitions occur, an integration of different systems should be managed. In our setting, we performed the integration of four different PV systems in a new Head-quarter (HQ)-Affiliate model in the EU context. This occurred through the harmonization and enhancement of procedures and development of tools, and the definition of centralized and peripheral roles, responsibilities, and activities. Challenges faced included the planning and managing safety data migrations from different storage types to a centralized database, maintaining a high level of compliance, requested by the current regulatory framework, while managing an increased amount of data. The scenario we had to deal with led different PV systems to be merged in an HQ-Affiliate model where Individual Case Safety Report (ICSR) management was under the responsibility of HQ. The centralization of data collection, coding, and evaluation ensured higher standards, consistency and value to data quality and system performance.

The integration also implied the setup of a quality-based safety evaluation and risk management system. The overall process led to gather better knowledge and understanding of product’s safety profile, to assess gaps and to plan continuous monitoring activities.In our integrated HQ-Affiliate model, we performed an impact analysis to ensure a quality and consistent system through the whole organization. Of course, the integration of PV systems has had an impact on PV agreements and contracts. In order to address this challenge specific gover-nance has been established with overall responsibilities over PV contracts.

The integration of different PV systems should consider an in-depth analysis of impacted critical processes, and adequate resources should be allocated. Such integrations imply deep renovation over the system but also offer the opportunity to improve and streamline processes.

Pharmacovigilance is an essential component of pharmaceutical safety. The United Journal of Pharmacovigilance opens a new space for the dissemination of scientific data in this area of research, based on the methodological and operational principles of clinical research and its implementation in the context of evidence-based decision-making. This short communication aims to highlight the importance of access-ing clinical records to perform retrospective evaluations of drug safety issues. We will focus particularly on pandemic situations, as the present COVID-19.

Pharmacovigilance plays a major role before and after the drug devel-opment process. In this article, a detailed explanation of the pharma-covigilance actives and the benefit-risk evaluation has been discussed.

Every drug or medicinal product undergoes clinical phases when coming to the market approval, and they have a benefit-risk ratio of their own. Pharmacovigilance helps in providing the safety profile of the drug or medicinal product and finds the risks. It ensures the continued protection of medicinal products in the pharmaceutical and health care industries and aims to improve patient care and protection through the selection, monitoring, and communication of drug safety in relation to the use of medicines. Pharmacovigilance defines as “The science and activities re-lating to the detection, evaluation, understanding, and prevention of ad-verse reactions to medicines or any other medicine-related problems”

The Development Safety Update Report (DSUR) is a standard document for periodic reporting covering safety information of drugs, biologicals, vaccines, and combination products under clinical development among the ICH regions. DSUR is also prepared and submitted for marketed drugs that are under further clinical study for another indication. Every investigational drug need to undergo all phases of a clinical trial to prove its safety and efficacy. The DSUR is an important tool to study the safety and risk profile of an investigational drug periodically. The DSUR aims to provide periodic analysis of the emerging safety profile of an investigational drug; actions proposed or being taken, any changes in IB, subject exposure, lack of efficacy from trials and safety findings from non-interventional studies of an investigational drug. In clinical practice, monitoring of subjects is less intensive, broader range of subjects are treated (age, co-morbidities, drugs, genetic abnormalities), and events too rare to occur in clinical trials may be observed. Such factors underlie the need for continuous evaluation of emerging risk, new safety, efficacy, and effectiveness information throughout the development of an investigational drug, and such information should be reported in DSUR periodically. This article gives an overview of the importance, context, purpose, scope, sections, timelines for regulatory submissions of DSUR, which will advantageous to all periodic reports writers and pharmacovigilance professionals.

No effective medicine is without risk and the use of medicines has become more complex than ever before! While medicines bring significant benefits, there are also inherent risks to public health and patient safety mainly due to adverse reactions. Adverse drug reactions (ADRs) are an important public health issue because of high morbidity, mortality and cost that they generate [1]. Specifically, every medicine can have both wanted and unwanted effects which may occur in some or all patients. It is precisely for this reason that the benefits of medicinal product should always be weighed up against its risks and failing to manage the risks may lead to crisis situations with harmful consequences for patient safety and public health. Because of the strong impact in public health, regulatory authorities (RAs) worldwide have raised the bar and have implemented new pharmacovigilance legislation to protect public health by reducing the burden of ADRs through the detection of safety signals. Although, signal detection activities have mainly been performed based on spontaneous reporting databases, new pharmacovigilance legislation underlines the relevance of other sources of information e.g. scientific literature, epidemiology, large automated databases for the evaluation of the benefit–risk balance of medicinal product.