Academic literature on the topic 'Pharmacovigilance Indicators'

Monitoring the safety of medicines used in public health programs (PHPs), including the neglected tropical diseases (NTD) program, is a WHO recommendation, and requires a well-established and robust pharmacovigilance system. The objective of this study was to assess the pharmacovigilance systems within the NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania. The East African Community Harmonized Pharmacovigilance Indicators tool for PHPs was used to interview the staff of the national NTD programs. Data on four components, (i) systems, structures, and stakeholder coordination; (ii) data management and signal generation; (iii) risk assessment and evaluation; and (iv) risk management and communication, were collected and analyzed. The NTD programs in the four countries had a strategic master plan, with pharmacovigilance components and mechanisms to disseminate pharmacovigilance information. However, zero individual case safety reports were received in the last 12 months (2017/2018). There was either limited or no collaboration between the NTD programs and their respective national pharmacovigilance centers. None of the NTD programs had a specific budget for pharmacovigilance. The NTD program in all four countries had some safety monitoring elements. However, key elements, such as the reporting of adverse events, collaboration with national pharmacovigilance centers, and budget for pharmacovigilance activity, were limited/missing.

Pharmacovigilance, the scientific discipline pertaining to drug safety, has been studied extensively and is progressing continuously. In this field, medical informatics techniques and interpretation play important roles, and appropriate approaches are required. In this study, we investigated and analyzed the trends of pharmacovigilance systems, especially the data collection, detection, assessment, and monitoring processes. We used PubMed to collect papers on pharmacovigilance published over the past 10 years, and analyzed a total of 40 significant papers to determine the characteristics of the databases and data analysis methods used to identify drug safety indicators. Through systematic reviews, we identified the difficulty of standardizing data and terminology and establishing an adverse drug reactions (ADR) evaluation system in pharmacovigilance, and their corresponding implications. We found that appropriate methods and guidelines for active pharmacovigilance using medical big data are still required and should continue to be developed.

Introduction: Herbal medicines (HMs) have shown therapeutic and toxicological potentials. Thus, the WHO expanded the pharmacovigilance (PVG) scope to include HMs. This study appraised the state of PVG system in Nigeria for the safety monitoring of HMs using WHO core PVG indicators. Methods: Between January and June 2019, 39 PVG experts were requested to independently appraise the PVG system in Nigeria for safety monitoring of HMs using WHO PVG core structural (CSIs), process (CPIs) and outcome (COIs) indicators. The 27 indicators (CSIs = 10, CPIs = 9 and COIs = 8) were scored 3, 2, 1 and 0 for adequate, fairly adequate, inadequate and uncertain states, respectively. CSIs index (CSII) was determined by dividing the summation of CSIs mean score by total obtainable score (30) and expressed in percentage. This was applied to CPIs and COIs to obtain CPIs index (CPII) and COIs index (COII), respectively. Results: The mean ± standard deviation (SD) of participants’ age was 43.6 ± 10.3 years with mean ± SD work experience of 15.3 ± 9.3 years. Majority had doctoral degree (35.9%; 14/39; P >0.05) and were medical doctors (28.2%; 11/39; P > 0.05). Twelve of the 27 indicators scored at least 2.0 and CSIs, CPIs, and COIs accounted for 75.0% (9/12), 0.0% (0/12) and 25.0% (3/12), respectively (P < 0.05). The total mean score was 27.3 ± 0.2 for CSIs as against 8.0 ± 0.3 for CPIs and 11.2 ± 0.4 for COIs (P < 0.05). The CSII, CPII and COII were 91.0%; 29.6% and 46.7%, respectively (P < 0.05). Conclusion: Most of the structural elements are in place for safety monitoring of HMs in Nigeria. However, the process and outcome of PVG indicate an inadequate state. Thus, deliberate efforts are required to ensure the realization of PVG objectives.

Introduction. Ensuring the safety of medicines is the basis for the existence and functioning of any pharmacovigilance system as a type of activity aimed at obtaining and processing information about the undesirable consequences of the use of medicines. The objective of the paper is to identify the features of functioning of international and regional pharmacovigilance systems on the basis of the study conducted. Materials and Methods. To achieve the objective set, the authors have conducted a literature search and performed systemic analysis of the available publications and information presented on the websites of regulatory authorities in different countries. Comparative methods of analysis of the existing pharmacovigilance systems by the types of their organization and functioning in individual countries have been used with further analysis of the indicators of adverse drug reactions reporting. Results. The performed analysis of the peculiarities of functioning of pharmacovigilance systems has made it possible to identify several types of collecting information on adverse drug reactions (the centralized, decentralized, and mixed types), as well as to determine their strengths and weaknesses. It has been revealed that the maximum indicator of the average number of received spontaneous reports of adverse drug reactions per 1 million people a year was registered in countries practicing the centralized type of pharmacovigilance organization. Lower rates have been observed in countries using the decentralized or mixed pharmacovigilance systems. Discussion and Conclusion. The revealed features of the described approaches seem to be important for further improvement of the organization of work of the state system for monitoring the safety of medicines in the Russian Federation and the CIS countries. The use of the centralized type of organization of the pharmacovigilance system promotes active involvement of all actors involved in circulation of medicines, as well as helps to achieve a higher level of expert skills in assessing adverse drug reactions reporting, which contributes to the qualitative analysis of the information received and the timely adoption of regulatory decisions in order to improve safety of patients.

Many patients require multi-drug combinations, and adverse event profiles reflect not only the effects of individual drugs but also drug–drug interactions. Although there are several algorithms for detecting drug–drug interaction signals, a simple analysis model is required for early detection of adverse events. Recently, there have been reports of detecting signals of drug–drug interactions using subset analysis, but appropriate detection criterion may not have been used. In this study, we presented and verified an appropriate criterion. The data source used was the Japanese Adverse Drug Event Report (JADER) database; “hypothetical” true data were generated through a combination of signals detected by three detection algorithms. The accuracy of the signal detection of the analytic model under investigation was verified using indicators used in machine learning. The newly proposed subset analysis confirmed that the signal detection was improved, compared with signal detection in the previous subset analysis, on the basis of the indicators of Accuracy (0.584 to 0.809), Precision (= Positive predictive value; PPV) (0.302 to 0.596), Specificity (0.583 to 0.878), Youden’s index (0.170 to 0.465), F-measure (0.399 to 0.592), and Negative predictive value (NPV) (0.821 to 0.874). The previous subset analysis detected many false drug–drug interaction signals. Although the newly proposed subset analysis provides slightly lower detection accuracy for drug–drug interaction signals compared to signals compared to the Ω shrinkage measure model, the criteria used in the newly subset analysis significantly reduced the amount of falsely detected signals found in the previous subset analysis.

e13579 Background: The antineoplastics are considered drugs with a high number of side effects. Paradoxically, in the National Network of Pharmacovigilance the number of reported adverse reactions of these medicine is proportionally lower than that of normal drugs. In the field of pharmacovigilance programs promoted by the Region Emilia Romagna and funded by AIFA (Italian Medicines Agency) a project of multicenter surveillance of cancer drugs and their effect has been developed aimed at improving patient safety. The project joined 7 centers: IRCCS IRST (Coordinating Center) and the Hospitals of Ravenna, Parma, R. Emilia, Bologna, Ferrara and Rimini. Methods: All centers except one used the management software Log80 and therefore shared a database of information of analogous structure (the data presented come from the database of medication prescription). The survey included patients that started therapy in 2011 and reduced it in the same year. It was analyzed dose reduction from 10% to 50% during the first 90 days of therapy (dose reduction was counted from the actual administred dose to patient). The first 90 days of therapy have been considered as a significant time frame to intercept critical phenomena. Results: Out of a total of 12,389 patients, 1,320 have reduced the dose in the firts 3 mounth of treatment (10.7%). The drugs that have mostly resulted in a reduction of dose were Paclitaxel and Oxaliplatin (with a reduction of respectively 17.4% and 17.3% in term of number of patients ), Docetaxel (14.8%), Carboplatin (15%), Fluorouracil (10.7%) and among oral medications Capecitabine (6.9%). Conclusions: This survey has shown that patients treated with chemotherapy have had a dose reduction lower than compared to published studies. With regards to these reduction it must be highlighted that approximately 20% of patients have reduced by 30% the dose within three months of therapy. The dose reduction may underlie suspected adverse reactions; in this perspective, further investigations could show if the patients had severe adverse drug reactions.

Introduction: Eye care is imperative and requires that ophthalmic prescriptions be generated properly. Evaluation of prescription pattern is an aspect of investigation of drug utilization which is an essential part of pharmacoepidemiology and pharmacovigilance. Objectives: To determine the prescription pattern in the eye clinic of a health facility using the WHO core prescribing indicators and document the disease pattern according to the prescriptions. Methods: The study was conducted at the Eye Clinic of the University of Calabar Teaching Hospital (UCTH), Nigeria. Data were collected retrospectively from prescriptions (from January to December 2018) in the Pharmacy using the WHO core indicator form. Microsoft Excel® was used to organize and analyse collected data using descriptive analysis. Ethical approval was obtained from the health research ethics committee of UCTH, Calabar. Result: A total of 1098 prescriptions were accessed over the 12-month study period, 48% (531) of which were for females and 83% (915) for adults. Average number of drugs per prescription was 1.8. The percentage of drugs by generic name was 38.8%, drugs prescribed from essential drug list was 28.7% and antibiotics prescribed was 31.3%. Glaucoma (23%), conjunctivitis (19%) and refractive error (17%) were the most prevalent eye diseases found. Conclusion: Prescription pattern in this study site conformed to only one of the five WHO drug use indicators. High antibiotics prescriptions were observed, and eye diseases associated with bacterial infections were most prevalent in this study. Drugs should be prescribed with generic names and the essential drugs lists should be expanded to accommodate more drugs for glaucoma.

Abstract Background The European Medicines Agency Good Pharmacovigilance Practices (GVP) guidelines provide a framework for pharmacovigilance (PV) audits, including limited guidance on risk assessment methods. Quality assurance (QA) teams of large and medium sized pharmaceutical companies generally conduct annual risk assessments of the PV system, based on retrospective review of data and pre-defined impact factors to plan for PV audits which require a high volume of manual work and resources. In addition, for companies of this size, auditing the entire “universe” of individual entities on an annual basis is generally prohibitive due to sheer volume. A risk assessment approach that enables efficient, temporal, and targeted PV audits is not currently available. Methods In this project, we developed a statistical model to enable holistic and efficient risk assessment of certain aspects of the PV system. We used findings from a curated data set from Roche operational and quality assurance PV data, covering a span of over 8 years (2011–2019) and we modeled the risk with a logistic regression on quality PV risk indicators defined as data stream statistics over sliding windows. Results We produced a model for each PV impact factor (e.g. 'Compliance to Individual Case Safety Report') for which we had enough features. For PV impact factors where modeling was not feasible, we used descriptive statistics. All the outputs were consolidated and displayed in a QA dashboard built on Spotfire®. Conclusion The model has been deployed as a quality decisioning tool available to Roche Quality professionals. It is used, for example, to inform the decision on which affiliates (i.e. pharmaceutical company commercial entities) undergo audit for PV activities. The model will be continuously monitored and fine-tuned to ensure its reliability.

L’évolution du système de pharmacovigilance au Nigéria a été associée à une croissance modeste et les hôpitaux universitaires ont été identifiés comme des partenaires importants du système de pharmacovigilance. Cependant, aucune étude n'a encore été réalisée sur les performances du système de pharmacovigilance dans les hôpitaux universitaires nigérians. Cette étude visait à évaluer l'état de la pharmacovigilance, en particulier les réactions indésirables aux médicaments dans le sud et le sud du Nigéria, en se référant à des médicaments sélectionnés. Le système de pharmacovigilance ainsi que le schéma posologique des médicaments ont été évalués à l'aide des indicateurs de pharmacovigilance de base de l'OMS et des indicateurs de prescription de base de l'OMS, respectivement. Cela a été suivi d'une intervention éducative avec des messages texte envoyés via le système de messagerie courte (SMS) pour améliorer les connaissances, l'attitude et la pratique de la pharmacovigilance parmi les professionnels de la santé. Le nombre, la qualité et le profil des effets indésirables du médicament ont également été évalués avant et après l'intervention. Les facteurs probables susceptibles de contribuer à une mauvaise notification des problèmes de pharmacovigilance ont été recherchés en effectuant une enquête sur les connaissances, la sensibilisation et les pratiques des professionnels de la santé travaillant dans la zone. Ces faiblesses de la pharmacovigilance étaient essentiellement. Les résultats ont montré que des structures étaient en place pour les activités de pharmacovigilance, même si certaines étaient peu fonctionnelles. Les indicateurs de processus et de résultat / impact ont révélé des systèmes de santé faibles et une attention générale insuffisante à la pharmacovigilance dans les hôpitaux. Il a également montré que, même si le groupe possédait une connaissance modeste et une perception juste de la pharmacovigilance, la pratique était médiocre et peu de réactions indésirables au médicament étaient répertoriées dans les bases de données des hôpitaux locaux. Celles-ci ont été attribuées à une connaissance insuffisante de la pharmacovigilance sur ce qui peut être signalé, à des processus de notification médiocres, à de fausses croyances selon lesquelles leur notification ne fera aucune différence et à la difficulté de déterminer les éléments à signaler. Une perception insuffisante de l’intérêt de la notification des effets indésirables. Les connaissances et les pratiques en matière de pharmacovigilance se sont améliorées, de même que le nombre de déclarations d'effets indésirables au médicament suite à une intervention éducative. Cette étude a également mis en évidence le profil des effets indésirables associés aux médicaments couramment utilisés dans la zone et les problèmes inhérents à la notification spontanée. Il souligne également que la pharmacovigilance, discipline en pleine croissance, peut être améliorée par des évaluations fréquentes du système, la formation des professionnels de la santé et le renforcement général du système de santé nigérian. Des études plus approfondies seraient nécessaires pour mieux évaluer la sécurité des médicaments dans cette population noire homogène
The evolution of the pharmacovigilance system in Nigeria has been associated with modest growth and teaching hospitals have been identified as important partners in the pharmacovigilance mechanism. However, there have been no studies evaluating the performance of the pharmacovigilance system in Nigerian Teaching hospitals prior to this time. This study set out to evaluate the state of pharmacovigilance specifically adverse drug reactions in South-South Nigeria. The pharmacovigilance system as well as the prescribing pattern of medicines was evaluated using the WHO Core Pharmacovigilance indicators and WHO Core Prescribing indicators respectively. This was followed by an educational intervention with text messages sent via the Short Messaging System (SMS) to improve the knowledge, attitude and practice of pharmacovigilance amongst healthcare professionals. The number, quality and profile of Adverse Drug Reactions (ADRs) were also assessed before and after the intervention. Factors likely to contribute to poor reporting of pharmacovigilance issues were sought by conducting knowledge, awareness, and practice survey of healthcare professionals working in the zone.The findings showed that of the six teaching hospitals assessed, only three could be described as functional or partly functional although all had some structures in place for pharmacovigilance activities. The process and outcome/impact indicators revealed weak health systems and overall insufficient attention to pharmacovigilance in the hospitals as only one centre had committed their ADR reports to the National Pharmacovigilance Centre and there were few documented medicines related admissions ranging from 0.0985/1000 to 1.67/1000 admissions. It further showed that although a modest knowledge and fair perception of pharmacovigilance existed among the group, practice was poor as only 12% of the 811 healthcare Professionals had ever used the national ADR reporting form and there were few adverse drug reaction reports in the local hospital databases. These were attributed to insufficient awareness of pharmacovigilance on what can be reported, poor reporting processes, wrong beliefs that their reporting will not make a difference and difficulty in determining what to report. There was an improvement in the knowledge and practice of pharmacovigilance, with a 31.6% increase in the number of adverse drug reaction reports following an educational intervention. This study also highlighted the ADR profile to commonly used medicines in the zone and the inherent problems associated with spontaneous reporting. It further highlights that the growing discipline of pharmacovigilance can be improved through frequent assessments of the system, training of the healthcare professionals and general strengthening of the Nigerian healthcare system. More in-depth studies would be required to further evaluate the safety of medicines in the Nigerian population

Para introducir un programa de farmacovigilancia en pacientes con nutrición enteral domiciliaria (NED) se realiza un estudio observacional prospectivo y estadístico de una cohorte de pacientes del programa NED de la zona sanitaria de Lleida entre octubre de 2003 y junio de 2005. Se estudiaron 79 pacientes, edad media de 73 años y proporción V/H del 50%. Patologías predominantes neurológicas y oncológicas. Mortalidad del 48,1%. No hay diferencias significativas de mortalidad entre pacientes neurológicos y oncológicos ni entre los pacientes con problemas relacionados con los medicamentos (PRM) y los que no. La NED se administra mayoritariamente por vía gástrica (nasogástrica y gastrostomía) y la dieta predominante estándar normocalórica. La administración de fármacos fue de casi 6 fármacos por paciente (5,7 ± 3), con un 86,4% de pacientes que toma más de 3 fármacos, mayoritariamente triturados. Ocurren 84 complicaciones/interacciones, de las cuales 72 (85,7%) son PRM, mayoritariamente EM y RAM. Un 40% de pacientes no tienen ningún PRM. Los PRM no influyen en la mortalidad ni en los marcados nutricionales pero sí aumentan la carga de trabajo del equipo NED (mayor número de visitas y actuaciones). En conclusión, los pacientes con NED son habitualmente polimedicados y presentan frecuentes interacciones/complicaciones entre la nutrición enteral y los fármacos pero no tienen repercusión en la mortalidad ni en la evolución nutricional, aunque sí aumentan las cargas de trabajo. Un programa de farmacovigilancia con indicadores de estructura, proceso y resultado puede contribuir a un mejor control de calidad.
Per introduir un programa de farmacovigilància en pacients amb nutrició enteral domiciliària (NED) es realitza un estudi observacional prospectiu i estadístic d'una cohort de pacients del programa NED de la zona sanitària de Lleida entre octubre de 2003 i juny de 2005. Es van estudiar 79 pacients, edat mitjana de 73 anys i proporció V / H del 50%. Patologies predominants neurològiques i oncològiques. Mortalitat del 48,1%. No hi ha diferències significatives de mortalitat entre pacients neurològics i oncològics ni entre els pacients amb problemes relacionats amb els medicaments (PRM) i els que no. La NED s'administra majoritàriament per via gàstrica (nasogàstrica i gastrostomia) i la dieta predominant estàndard normocalórica. L'administració de fàrmacs va ser de gairebé 6 fàrmacs per pacient (5,7 ± 3), amb un 86,4% de pacients que pren més de 3 fàrmacs, majoritàriament triturats. Ocorren 84 complicacions / interaccions, de les quals 72 (85,7%) són PRM, majoritàriament EM i RAM. Un 40% de pacients no tenen cap PRM. Els PRM no influeixen en la mortalitat ni en els marcadors nutricionals però sí augmenten la càrrega de treball de l'equip NED (major nombre de visites i actuacions). En conclusió, els pacients amb NED són habitualment polimedicats i presenten freqüents interaccions / complicacions entre la nutrició enteral i els fàrmacs però no tenen repercussió en la mortalitat ni en l'evolució nutricional, encara que sí augmenten les càrregues de treball. Un programa de farmacovigilància amb indicadors d'estructura, procés i resultat pot contribuir a un millor control de qualitat.
To enter a pharmacovigilance program in patients with home enteral nutrition (HEN) performing a prospective observational and statistical study of a cohort of patients from the HEN program health area of Lleida between October 2003 and June 2005. We studied 79 patients, mean age of 73 years and ratio men/women of 50%. Predominant neurological and oncological diseases. Mortality of 48.1%. No significant differences in mortality between neurological and oncological patients or between patients with drug-related problems (DRPs) and those without. The HEN is administered mainly by gastric route (nasogastric and gastrostomy) and diet predominantly consisting of normal standard. Drug administration was 6 drugs per patient (5.7 ± 3), with 86.4% of patients taking more than 3 drugs, mostly crushed. Complications occur 84 / interactions, of which 72 (85.7%) are DRP, mostly ME and ADR. About 40% of patients have no DRP. The DRP does not affect mortality or the nutritional state but increase the workload of HEN team (more visits and performances). In conclusion, patients with HEN are usually polypharmacy and have frequent interactions / complications between enteral nutrition and drugs but have no impact on mortality or nutritional changes, although increased workloads. A pharmacovigilance program with indicators of structure, process and results can contribute to a better quality control.

The discovery of a new drug usually takes 10-15 years. Within this time period, the candidate drug is thoroughly screened for its beneficial as well as side effects. But the side, adverse or toxic effects cannot be detected to a full scale due to some special reasons. The beneficial effects and toxicity of new drugs and vaccines are usually studied by “Clinical trials”, which are divided into four categories ranging from clinical trial phases I to IV. During clinical trial phase-III, about 4,000-10,000 patients are involved and after passing this phase, the drug is allowed to enter into the global market. Then, billions of people, including those who were excluded in phase-III, may be administered with this drug. It is worthy to mention that these 4,000-10,000 patients may not show many of the side effects or toxic actions. The undetected adverse drug reactions (ADRs) are studied in clinical trial phase-IV, which is also known as post market surveillance. For this reason, the ADRs are compared with the tip of the iceberg, as it indicates the minor part of a major event. This phenomenon gave birth to a new branch of the pharmacology known as Pharmacovigilance.