Pharmacovigilance Department Research Articles

Analysis of Errors Identified during Regulatory Review of Risk Management Plans Submitted as Part of Registration Dossiers

Scientific relevance. On 6 December 2022, an updated version of the Rules for Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP) came into force. The greatest changes were made to the requirements for pharmacovigilance documents, particularly the risk management plan (RMP). In practice, the changed EAEU GVP has resulted in multiple errors, creating the need to thoroughly analyse their structure and causes and to develop recommendations for their prevention.Aim. This study aimed to identify, analyse, and collate inconsistencies between the information submitted by marketing authorisation holders in their RPMs and the updated EAEU GVP requirements.Materials and methods. The Scientific Centre for Expert Evaluation of Medicinal Products analysed 50 RMPs received after 6 December 2022 as part of registration dossiers aimed to support marketing authorisation applications and/or align the registration dossiers with the EAEU requirements.Results. The errors made by applicants when preparing RMPs were categorised according to their influence on the interpretation of a medicinal product’s safety profile. The errors leading to incorrect safety profile interpretations were considered type 1 errors (63% of the cases). The errors affecting the perception of the RMP but not the interpretation of the safety profile (e.g., grammatical errors, notes and comments by applicants, incorrect translation of terms) were deemed type 2 errors (37% of the cases). The majority of EAEU GVP noncompliance cases were detected in Part II of the RMP, the section providing the most information on the safety profile of a medicinal product.Conclusions. There are several ways to improve the quality of RMP preparation. The information included in the RMP should be compared with the information provided in the registration dossier. The RMP should be incorporated into the integrated pharmaceutical quality system according to the requirements of good practices.A responsible employee of the marketing authorisation holder’s quality assurance system should control the final RMP version. Employees of pharmacovigilance departments should receive regular training.

From pharmacovigilance to pharmaceutical care: About a case of urticaria and angioedema

The concept of “pharmaceutical care” was developed in 2017 in Algeria to globally define the practice of clinical pharmacy. The EHU Oran pharmacovigilance department has thus benefited from the integration of pharmaceutical care to improve drug management. We report a clinical case of urticaria and angioedema in a 22-year-old female patient in a context of polymedication with non-steroidal anti-inflammatory drugs (NSAIDs). A notification was sent to the pharmacovigilance department to estimate the causality assessment. The aim of our article is to illustrate the integration of pharmaceutical care system with the pharmacovigilance, based on this clinical case.

Processing of Individual Case Safety Reports in The Pharmacovigiland Department of Indonesian Vaccine Companies

This study aimed to determine and analyze the processing design of individual case safety reports in Indonesia's pharmacovigilance department of vaccine companies. This study combines qualitative and quantitative studies that propose implementing the new artificial intelligence system for the PV Department. The results obtained from this study are problem-solving solutions by increasing the number of staff, using artificial intelligence (AI) technology in AEFI case processing to avoid errors and manual input, and approaching external stakeholders to be able to report safety data efficiently and more structured. With the addition of human resources to process the AEFI reporting data by one person, performance value will be increased to 165%. If the process utilizes AI technology, case processing performance increases to 219%. disruption of the performance of the pharmacovigilance department in Indonesian biopharmaceutical companies can be caused by the pandemic disrupting the way KIPI cases are reported, so the solution is the addition of human resources, changes in processes and SOPs, as well as approaches to external stakeholders to streamline case processing.

Reporting Antimicrobial-Related Adverse Drug Events in Jordan: An Analysis from the VigiBase Database

This study aims to assess the reporting of antimicrobial-related adverse drug events (ADEs) in Jordan between 2003 and 2022. Data regarding the antimicrobial-related ADEs were extracted from the WHO's global database (VigiBase) by the Rational Drug Use and Pharmacovigilance Department at the Jordan Food and Drug Administration (JFDA). A total of 279 Individual Case Safety Reports (ICSRs) were recorded. The number of ICSRs increased from 2019 onwards (219 out of 279 cases). This increase in the reported ADEs was influenced by the actions of the JFDA, including the introduction of electronic reporting forms, updating the national pharmacovigilance guidelines, which encouraged adverse drug reactions reporting, the implementation of the AMR-national action plan, the encouragement to report due to COVID-19 vaccine, and the continuous awareness campaigns and training programs. Skin and subcutaneous tissue disorders (n = 105; 19.48%) were the most reported antimicrobial-related ADEs. The highest number of ADEs was reported for tetracyclines (n = 101; 18.74%) followed by fluoroquinolones (n = 54; 10.02%), third-generation cephalosporines (n = 48; 8.9%), and carbapenems (n = 42; 7.79%). From the top 10 consumed antibiotics, the number of ADEs in patients who consumed Watch group antibiotics (97 ADEs) was higher than those who consumed Access group antibiotics (28 ADEs). The findings highlight the need to monitor and rationalize the use of Watch antibiotics. Enhanced reporting of antimicrobial-related adverse drug reactions is needed to inform antimicrobial stewardship and improve the pharmacovigilance system in Jordan.

Pharmacovigilance: Study of pattern of adverse drug reactions at a tertiary care teaching hospital, Aurangabad, and Maharashtra, India: A prospective study and forthcoming challenge for the future

Background: Reporting adverse drug reaction (ADRs) through Pharmacovigilance program of India is very important for effectiveness of drug treatment. It allows professionals to detect, assess, monitor and derive ways to reduce the incidence of ADRs. Aims and Objectives: The aim of the study was to study the patterns of ADRs reported in a tertiary care teaching hospital. Material and Methods: This study was conducted for a period of 10 months. We included all the forms of ADRs caused by drugs which were sent to the Pharmacovigilance cell, Department of Pharmacology. The reports were analyzed for age group, anatomical therapeutic classification, organ system involvement, type, severity, and the causality assessment. Results: A total of 104 ADRs form were analyzed. The highest percentage 59.6% of ADRs was seen in 19–59 years of age group. Females were reported more reactions. The most common class of drugs involved was antimicrobial agents (51.9%). Major organ system affected was skin constituted a major component (73.0%). Our study showed that 75% reactions were predictable while 13.4% were unpredictable reactions. About 51.9% of reactions were moderate according to severity grading. The WHO causality assessment showed that 37.5% reactions were probable/likely and 32.6% were possible. About 75.9% of patients suffered from temporary harm and require intervention while 17.3% requires hospitalization. About 53.8% of reactions were from definitely preventable category and 43.2% were probably preventable. Conclusion: The results suggest that staff of our hospital is reporting ADR according to the guidelines. There will be increase in spontaneous reporting and decrease in number of ADRs with further reinforcement. The data generated from Pharmacovigilance department will also help in finding ways for safer use of drugs in our hospital.

АНАЛИЗ РУТИННЫХ МЕР МИНИМИЗАЦИИ РИСКОВ ПРИМЕНЕНИЯ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ ПРОИЗВОДСТВА РУП «БЕЛМЕДПРЕПАРАТЫ» НА ТЕРРИТОРИИ РЕСПУБЛИКИ БЕЛАРУСЬ

Today, it is of great importance to timely inform health care professionals and patients about the risks associated with the use of medicinal products (MP) in order to minimize the development of undesirable effects of pharmacotherapy. The easiest way to convey this information to the end-user is to make changes in the general characteristics of a medicinal preparation (SmPC) and the instruction for medical use (IFU)/package leaflet (PL). To maintain up-to-date information in the SmPC and IFU/PL, it is necessary to constantly monitor new information on the efficacy and safety of medicinal products. The article presents data on the implementation of routine risk minimization measures associated with the discovery of new and relevant information on safety in relation to MP produced by RUE «Belmedpreparaty» in 2018-2020. At the moment, the company produces a wide range of medicines, therefore, the implementation of constant monitoring of such information for further updating of information about the drug is an important link in the work of the pharmacovigilance department.

Pharmacovigilance – possible career journey for pharmacists

After graduating from the Pharmacy School, there are several career paths that a young professionals can follow. One of the many opportunities to start the career is working for a pharmaceutical company, in the Department of Pharmacovigilance, that has the main goal the patient‘s safety. There are different types of activities that make up a highly effective pharmacovigilance system which supports the medicine throughout its lifecycle, from the first human studies to the post marketing phase. The aim of this article is to describe a personal experience after nine years of working in the field of pharmacovigilance of several pharmaceutical companies, to raise awareness among healthcare professionals regarding the importance of reporting of the adverse events and to share how pharmaceutical companies use this information to continuously monitor the safety of their medicines.

Safety profile of an oral nasal decongestant/antihistamine combination in pediatrics: a real-world experience/ Perfil de segurança de uma combinação de descongestionante nasal e anti-histamínico em crianças: uma experiência de mundo real

Objective The objective of this work is to characterize the safety profile of phenylephrine and brompheniramine in pediatric patients through the evaluation of post-marketing pharmacovigilance data. Method: Adverse events and situations grouped as medication errors, occurring in patients aged from zero to 12 years exposed to Decongex Plus received by the pharmacovigilance department of Aché Laboratórios Farmacêuticos during the period from 2/1/2014 to 9/30/2019 were included in this study. The events were grouped according to the age of the patients and classificated regard seriousness and expectedness. The data found were compared with other studies of the same gender and with international database. Results: A total of 1,391 adverse events occurred in patients aged between 0-12 years were included. The results showed a total incidence of adverse events of 0.0035% (rare according to local legislation). The majority (62.68%) occurred in the age group of 2 to 6 years of age. In this age group, 97.82% of the adverse events were considered non-serious, the majority being somnolence, and only 2.18% of the events were considered serious. In children over 7 years of age (8.62% of the total), it was also found that most adverse events (94.16%) were non-serious. The age group under two years of age totaled 28.68% of the adverse events received, with 98% being considered non-serious (main event was also somnolence) and 67% being medication errors. Conclusions: The study points to a favorable safety profile of phenylephrine and brompheniramine in pediatric patients. Randomized, controlled clinical studies are warranted to confirm these findings.

Influence of hepatic Graft-Versus-Host-Disease (GVHD) on the pharmacokinetics of ciclosporin in a case of acute myeloid leukemia treated at the EHU Oran

Acute myeloid leukemia (AML) is a malignant blood disease that affects hematopoietic cells in the bone marrow. The best treatment for AML is allogeneic hematopoietic stem cell transplantation (HSC). To prevent and treat the main complication of allogeneic marrow transplant, graft versus host disease (GVHD), it is necessary to combine immunosuppressive therapy which includes ciclosporin (CsA). The objective of our work is to study the influence of hepatic GVHD on the pharmacokinetics of cyclosporin in an AMLcase. This is an allografted patient (CSH), presented to our Pharmacovigilance department at the EHU of Oran in Algeria, with the aim of carrying out therapeutic pharmacological monitoring (TPM) of ciclosporin. We proceeded to assay for residual ciclosporinaemia from D1 of the allogeneic transplant. The patient presented a fluctuation of the trough concentrations, the explanation of which was an onset of acute hepatic GVHD, confirmed by biopsy with an elevated hepatic function, which represents an incidence varying between 10 and 50% in patients receiving transplant from a genoidentical donor. Without forgetting the great inter-individual and intra-individual variability of the response to ciclosporin, the environmental and pathological factors and the numerous drug interactions which can be the cause of modification of the pharmacokinetics and the pharmacodynamics of this drug. In conclusion, the pharmacological monitoring of cyclosporin, which is the treatment of choice to prevent or treat GVHD, is mandatory due to its low therapeutic index and high inter- and intra-individual variability.

Pharmacovigilance in generic Indian pharmaceutical industries - Need of the moment

Introduction: The pharmacovigilance department is liable for monitoring the safety of medicines during clinical trials and normal clinical use. The necessity of the pharmacovigilance department is an utmost requirement for effective regulations of the drug approval process and conscious pre and post-approval vigilance of the undesired effects, especially in India.
 Methods: In the light of the regulatory notification GSR 287(E) dated on 8th march 2016 by CDCSO, it has become clear that it is necessary to take measures to set up and improve the operation of the pharmacovigilance of medicinal products for human use in pharmaceutical companies. 
 Results: The regulators have also developed and posted Guidance document for marketing authorization holders (MAH) for Indian marketers and made clear that the MAH should be responsible for continuously monitoring the safety of its medicinal products for human use, for updating the health authorities of any changes related to the drug, and for ensuring that the product information is kept up-to-date. MAH should record all suspected adverse reactions occurring in the country, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of the post-authorization study.
 Conclusions: According to the Regulatory Guidance document, MAH is also responsible for the submission of the information on suspected adverse reactions of a newly approved drug or applicable product, in form of periodic safety update reports (PSURs), to the competent authorities.

Assessment of Prescription Medications for Indoor Patients and Effect of Interventions in a Medical College Hospital.

Bharati Vidyapeeth University Medical College Hospital and Research Centre in Pune, India has been a pioneer institute with 831 beds, with learned faculty, residents, and trained nursing and supportive staff. Top management decided to further improve quality and safety in patient care and accordingly felt the need to acquire accreditation under the banner of National Accreditation Board for Hospitals and Healthcare Providers (NABH). As a first step toward this, a quality assurance department was established and entrusted with the task to identify areas needing improvement. "Prescription profile of medications" was identified as one of the core areas needing improvement as medication errors are mostly due to faulty prescriptions. The aim of this study was to measure the compliance of indoor patient prescriptions towards standard guidelines. Top management of the hospital envisaged that preparing for NABH accreditations would be one of the tools for improving patient safety and quality. Hence, in addition to a quality assurance department, a separate department of clinical pharmacy and pharmacovigilance was also established, specifically to take care of medication safety, including prescription profile. Interventions were designed based on observations in the preintervention phase. Interventions included regular monitoring of prescriptions, medication safety, and repeated training sessions for physicians by the department of clinical pharmacy and quality assurance. Compliance by physicians regarding most of the components of prescriptions showed improvement. There has been a substantial reduction in medication errors (in patient days). The improvement in compliance of components of prescriptions and reduction in medication errors was attributable to applied interventions.

The Road to Pharmacovigilance Outsourcing Guidance

In this publication, the authors, having gained several decades of experience in Pharmacovigilance departments, both in pharmaceutical companies as well as in service providers companies, describe the reason why and the way how a guideline for outsourcing was created. While outsourcing in pharmacovigilance has become the rule rather than the exception in the last decade, a consensus guideline, based on best practice, appears to be missing. A group of committed professionals have given their time and knowledge to an iterative process of writing and reviewing drafts of such a guideline. One of the authors was closely involved with the writing as well as presenting the draft guidance at conferences. The other author was managing the process, including discussions, periodically reviewing the result, as well as responding to the reviewers' comments. In this publication, a high-level overview of the guideline is provided. The key message is that outsourcing in PV requires both a detailed preparation, including risk assessments of the various elements, as well as close contact with the service provider.

Naloxone as a trigger to identify opioid-related adverse events in pediatric intensive care units

Objective: this study had the objective to identify opioid-related Adverse Drug Events (ADE) with naloxone as a trigger and evaluate the patterns of naloxone administration in hospitalized children as well as verify the report of these ADE to the hospital’s pharmacovigilance department. Methods: a retrospective review of electronic medical records was conducted with records of pediatric patients who received naloxone from January 1st, 2015 to June 30th, 2016. Descriptive statistics and analysis of Variance (ANOVA) followed by Tukey’s test were performed to analyze the results (P < 0.05 was considered statistically significant). The study was conducted in a tertiary children’s hospital in Paraná, Brazil. Results: we found 58 opioid-related ADE (3.2 events/month) and an underreporting rate of 93% at the hospital. All of the events occurred in Intensive Care Units (ICU) while most of the patients were female (51.7%) and infants (from 1 month old to 24 months old) (51.7%) inside the Cardiac ICU (63.8%). Fentanyl was the most prescribed opioid (66.2%); apnea (29.31%) and insaturation (20.69%) were the most reported symptoms during the ADE. All opioid-related ADEs caused temporary harm to the patients and required intervention. However, only 2.8% of the patients presented ADE by opioid intoxication. The opioid-related ADE were not influenced by opioid types, age groups or patients’ diseases. Conclusions: these findings showed a higher incidence of opioid-related ADE inside the Cardiac ICU among infants and a significant underreporting rate of these ADE to the pharmacovigilance department. Our study strengthens the importance of the human factor as a possible cause of ADE in pediatric patients, as well as the challenge to manage patient’s safety in pediatric institutions.

Adverse Drug Reaction Case Safety Practices in Large Biopharmaceutical Organizations from 2007 to 2017: An Industry Survey.

Drug safety remains a top global public health concern. An increase in the number of data sources available has increased the complexity of pharmacovigilance operations, so the US FDA has created draft guidance focusing on optimizing drug safety data for well-characterized medicines. However, to date, no data demonstrating changes in reports have been presented. This study provided data assessing changes in individual case safety reports (ICSRs) and aggregate reports (ARs) for large biopharmaceutical companies from 2007 to 2017. This study also evaluated current trends on the use of advanced machine and deep learning in order to process all data captured for ICSRs as well as opinions from industry thought leaders on creating a sustainable case-processing operation. Using data captured from Navitas Life Science's annual pvnet® benchmark, we calculated workload indicators characterizing pharmacovigilance operations for large biopharmaceutical organizations. Workload indicators included the number of ICSRs by organization, the number of ARs, and the number and types of data sources used. We also conducted structured in-depth interviews with seven biopharmaceutical executives to discover the reasons for changes in workload indicators across time as well as current strategies for increasing efficiencies in drug safety reporting. The median number of ICSRs increased from 84,960 cases in 2007 to over 200,000 cases in 2017; this increase was largely attributable to an increase in both nonserious cases and follow-up cases. Member companies reported using 12 ± 3 data sources for case identification. The number of ARs also increased from a median of 70 reports in 2007 to 258 reports in 2017. To address these increases, 61% of the biopharmaceutical organizations we surveyed planned to adopt machine learning for full ICSR processing; however, as of 2018, none of the organizations surveyed had mechanisms in place. This study demonstrated that pharmacovigilance departments are currently burdened by ever-increasing case volumes. With increased guidance from regulatory agencies, as well as improvements in artificial intelligence and natural language processing, biopharmaceutical organizations must determine the most resource-efficient and sustainable methods to process the growing volume of cases.

Roussel Uclaf Causality Assessment Method for Drug-Induced Liver Injury: Present and Future.

Among the causality assessment methods used for the diagnosis of drug-induced liver injury (DILI), Roussel Uclaf Causality Assessment Method (RUCAM) remains the most widely used not only for individual cases but also for prospective and retrospective studies worldwide. This first place is justified by the characteristics of the method such as precise definition and classification of the liver injury, which determines the right scale in the scoring system, precise definition of the seven criteria, and the validation approach based on cases with positive rechallenge. RUCAM is used not only for any types of drugs but also for herbal medicines causing herb-induced liver injury, (HILI) and dietary supplements. In 2016, the updated RUCAM provided further specifications of criteria and instructions to improve interobserver variability. Although this method was criticized for criteria such as the age and alcohol consumption, recent consensus meeting of experts has recognized their value and recommended their incorporation into any method. While early studies searching for DILI in large databases especially in electronic medical records were based on codes of diseases or natural language without causality assessment, the recommendation is now to include RUCAM in the search for DILI/HILI. There are still studies on DILI detection or the identification of biomarkers that take into consideration the cases assessed as “possible,” although it is well known that these cases reduce the strength of the association between the cases and the offending compound or the new biomarker to be validated. Attempts to build electronic RUCAM or automatized application of this method were successful despite some weaknesses to be corrected. In the future, more reflections are needed on an expert system to standardize the exclusion of alternative causes according to the clinical context. Education and training on RUCAM should be encouraged to improve the results of the studies and the day-to-day work in pharmacovigilance departments in companies or in regulatory agencies. It is also expected to improve RUCAM with biomarkers or other criteria provided that the validation process replaces expert opinion by robust standards such as those used for the original method.

Intensive safety monitoring program of antineoplastic medicines: A pilot study in a Portuguese oncology hospital.

The aim of this study was to test the feasibility and the usefulness of an intensive safety monitoring program to identify adverse drug reactions for medicines under additional monitoring that are used to treat cancer patients within a Portuguese oncology hospital. This pilot intensive safety monitoring program was a three-month prospective, observational study. Patients undergoing treatment with one of the following medicines were included: nivolumab, olaparib, palbociclib, pembrolizumab, pertuzumab, ramucirumab, ribociclib, trastuzumab emtansine, or trifluridine/tipiracil. Potential eligible patients were identified by pharmacists based on prescription data. Clinicians used proper paper-based reporting forms to record adverse drug reactions. Clinical secretariats sent those reports through an electronic platform to the pharmacovigilance department for analysis. Seventy-five patients were on treatment with selected medicines. Of those, 33 (44%) experienced adverse drug reactions: 23 (69.7%) cases were serious and 5 (15.2%) unexpected. Considering the number of patients exposed to each medicine and the number of patients experiencing adverse drug reactions, trifluridine/tipiracil (72.7%; 8/11) was associated with the highest rate of toxicity, followed by olaparib (66.7%; 2/3), trastuzumab emtansine (50.0%; 3/6), pertuzumab (47.8%; 11/23), pembrolizumab (45.5%; 5/11), palbociclib (25.0%; 1/4), and nivolumab (18.8%; 3/16). A total of 59 adverse drug reactions were identified (i.e. 1.8 adverse drug reactions/patient), mainly gastrointestinal disorders (n = 15; 25.4%), and blood and lymphatic system disorders (n = 14; 23.7%). This intensive safety monitoring program was feasible and allowed identifying serious and unexpected adverse drug reactions, adding value to pharmacovigilance and therefore contributing to improve patient safety. Further research is needed to confirm the findings of this pilot study.

Piroxicam-induced fixed drug eruption: Cross-reactivity with meloxicam.

Non-steroidal anti-inflammatory drugs constitute a main cause of fixed drug eruption (FDE). A few cases of piroxicam-induced FDE have been reported; however, the cross-reactivity among oxicams has rarely been evaluated. To describe a series of patients with piroxicam-induced FDE, mostly confirmed by a positive patch test reaction, in whom cross-reactivity to meloxicam was assessed. We included all cases of piroxicam-induced FDE diagnosed in the department of pharmacovigilance of Monastir. Patch tests for piroxicam and meloxicam were performed in the involved skin according to the European Network on Drug Allergy recommendations. Oral provocation tests (OPTs) were performed for patients with negative skin test results. Seven patients were included in this study. FDE was multiple for five patients and solitary for two. Bullous eruption was noticed in two cases. Lesional patch tests for piroxicam gave positive results in six patients. To assess cross-reactivity with meloxicam, this was patch tested. The test gave a positive result in only one patient. OPTs with meloxicam gave positive results in two patients with negative patch test results. Meloxicam is not a safe alternative for the treatment of piroxicam-induced FDE, and OPTs can be used to confirm tolerance before this drug is prescribed as a safer alternative.

Safety assessment of seasonal trivalent influenza vaccine produced by Instituto Butantan from 2013 to 2017.

ABSTRACTVaccination has been a successful strategy in influenza prevention. However, despite the safety and efficacy of the vaccines, they can cause adverse events following immunization (AEFI). Moreover, due to the vaccination success, most of vaccine-preventable diseases (VPD) have become rare, and public attention has been shifted from VPD to the AEFI associated with vaccination. This manuscript describes the safety of Instituto Butantan (IB) seasonal trivalent influenza vaccine (TIV) from 2013 to 2017. AEFI data were received by the Department of Pharmacovigilance of IB (PV-IB), from January the 1st 2013 to December the 31st 2017, and were recorded in an electronic database (OpenClinica©). PV-IB received 1,415 Individual Case Safety Reports (ICSR) associated with the TIV; 1,253 ICSR with at least one AEFI were analyzed and 4,140 AEFI were identified. The other 162 (11.4%) cases did not present any symptom. Among the total of AEFI, 405 (9.8%) were classified as serious. AEFI with the highest incidence rates per 100,000 doses of TIV were: “local pain” (0.28), “local erythema” (0.23), “local warmth” (0.22), “local swelling” (0.20) and “fever” (0.19). PV-IB received 175 (4.2%) occurrences of SAE of special interest, of which 75 (1.8%) anaphylaxis/anaphylactic reactions, 56 (1.4%) neurological syndromes (including seven Guillain-Barré Syndrome) and 44 (1.1%) convulsion/febrile convulsion. The results of this manuscript suggested that Instituto Butantan trivalent influenza vaccine (IB-TIV) is safe, as most of the reported AEFI were classified as non-serious. AEFI described for the IB-TIV are in agreement with the ones described in the literature for similar vaccines.

Study of awareness of pharmacists about their work in the pharmacovigilance system in Ukraine and their professional activity

The role of the pharmacists in providing information on cases of adverse reactions (ARs) and/or lack of effectiveness of drugs in the Pharmacovigilance (PhV) Department of Ukraine is very important.
 Objective: Assessment of the level of pharmacists' awareness about regulatory documents (RDs) regulating their duties to provide information about ARs and/or lack of effectiveness of drugs and their activity in this area.
 The questionnaire for pharmacists was developed and used, the first seven questions of which were aimed at identifying pharmacists' awareness of their duties to provide information to the Department of PhV at the State Expert Center of the Ministry of Health of Ukraine about ARs and/or lack of effectiveness of drugs and their activity in filling the «Cards-message». Questioning of 70 pharmacists with different work experience (WE): 1‒5 years (12%), 5‒10 years (31%) and 10‒25 years (57%) was conducted.
 50% of pharmacists with 1‒5 years WE, 64% of pharmacists with 5‒10 years WE and 75% of pharmacists with 10‒25 years WE know about obligation to provide information about ARs and/or lack of effectiveness of drugs. Only 9% of pharmacists with 5‒10 years WE independently filled and sent the «Card-message» to the department of PhV, in most cases pharmacists give the filled form to the head of the pharmacy.
 Regardless of WE duration, the majority of pharmacists are aware the information about their responsibilities to provide reports about ARs and/or lack of drugs efficacy in the department of PhV and know the RDs that regulates this process. The inadequate activity of pharmacy workers to provide information about ARs and/or lack of effectiveness of drugs can be largely due to the low organization of this process at the pharmacy level and the conservatism of pharmacists with longer WE. It is advisable to increase the effectiveness of detection of ARs and/or lack of effectiveness of drugs due to activity of pharmacists in the conditions of pharmacy in Ukraine. Such professional activity of pharmacists helps to improve the quality of pharmaceutical care to the population of Ukraine.

Satisfaction des médecins généralistes d’un réseau d’aide à la déclaration de pharmacovigilance PharmacoMIP-MG

General practitioners (GPs) report little adverse drug reactions (ADR), although it is mandatory in France. The objective was to evaluate the satisfaction of the GPs who participated to a pharmacovigilance ADR declaration support network via a clinical research assistant (CRA) moving to their GP office in the French South-West region of Midi-Pyrénées. A satisfaction questionnaire was sent to the 59 active GPs of this network in November 2016. A total number of 44 GPs responded to the survey (mean age 44±11years; 48% of women). The overall satisfaction grade was rated 9/10 (SD±1). The personalized help from a CRA was highly appreciated(n=39; 89%), reduced time-loss (n=35; 90%), and facilitated communication with the local pharmacovigilance department (n=33; 85%). Most GP (95%; n=35) stated that they would keep reporting ADRs, 83% (n=35) stated to declare ADRs via the CRA, the others stated to declare ADRs directly to the Regional Pharmacovigilance Center, mainly via numerical or online tools. For 59% (n=26) their participation to the network had a positive impact on their relationship with patients through the improvement of their vigilance to ADR. Most of the active GP answered. They were very satisfied of the pharmacovigilance CRA network helping ADR reports. It may corroborate the increase of ADRs reporting in Midi-Pyrénées since this network was set up.