To see the other types of publications on this topic, follow the link: Pharmacovigilance Indicators.
Journal articles on the topic 'Pharmacovigilance Indicators'
Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles
Consult the top 50 journal articles for your research on the topic 'Pharmacovigilance Indicators.'
Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.
You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.
Browse journal articles on a wide variety of disciplines and organise your bibliography correctly.
1
Barry, Abbie, Sten Olsson, Christabel Khaemba, Joseph Kabatende, Tigist Dires, Adam Fimbo, Omary Minzi, et al. "Comparative Assessment of the Pharmacovigilance Systems within the Neglected Tropical Diseases Programs in East Africa—Ethiopia, Kenya, Rwanda, and Tanzania." International Journal of Environmental Research and Public Health 18, no. 4 (February 17, 2021): 1941. http://dx.doi.org/10.3390/ijerph18041941.
Full textAbstract:
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.
2
Shin, Hyunah, Jaehun Cha, Chungchun Lee, Hyejin Song, Hyuntae Jeong, Jong-Yeup Kim, and Suehyun Lee. "The 2011–2020 Trends of Data-Driven Approaches in Medical Informatics for Active Pharmacovigilance." Applied Sciences 11, no. 5 (March 4, 2021): 2249. http://dx.doi.org/10.3390/app11052249.
Full textAbstract:
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.
3
Balogun, Sulayman Tunde, Kenneth Okwong Okon, Ayodele Oluwasoji Akanmu, Leonard Mela Paul, and Olufunke Adebola Sodipo. "Safety monitoring of herbal medicines in Nigeria: worrying state of pharmacovigilance system based on WHO core pharmacovigilance indicators." Journal of Herbmed Pharmacology 10, no. 2 (January 7, 2021): 202–8. http://dx.doi.org/10.34172/jhp.2021.22.
Full textAbstract:
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.
4
Koryanova, Ksenia N., Alexander V. Matveev, Elena A. Egorova, and Elvira Yu Bekirova. "Features of International and Regional Pharmacovigilance Systems." REGIONOLOGY 28, no. 3 (September 30, 2020): 571–97. http://dx.doi.org/10.15507/2413-1407.112.028.202003.571-597.
Full textAbstract:
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.
5
Ejekam, ChiomaStella, Annie Fourrier-Réglat, and AmbroseO Isah. "Evaluation of pharmacovigilance activities in the national HIV/AIDS, malaria, and tuberculosis control programs using the World Health Organization pharmacovigilance indicators." Sahel Medical Journal 23, no. 4 (2020): 226. http://dx.doi.org/10.4103/smj.smj_46_19.
Full text
6
Noguchi, Yoshihiro, Tomoya Tachi, and Hitomi Teramachi. "Subset Analysis for Screening Drug–Drug Interaction Signal Using Pharmacovigilance Database." Pharmaceutics 12, no. 8 (August 12, 2020): 762. http://dx.doi.org/10.3390/pharmaceutics12080762.
Full textAbstract:
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.
7
Kshirsagar, Nilima A., Sten Olsson, and Robin E. Ferner. "Consideration of the desirable features and possible forms of practical indicators of the performance of pharmacovigilance centres." International Journal of Risk & Safety in Medicine 22, no. 2 (2010): 59–66. http://dx.doi.org/10.3233/jrs-2010-0495.
Full text
8
Tenti, Elena, Andrea Casadei Gardini, Dino Amadori, Paola Fiacchi, Alessandra Stancari, Alessandra Zanardi, Chiara Cherubini, et al. "Multicentric survey on dose reduction in cancer drug therapy: Detection and measurement of critical phenomena as potential indicators of suspected adverse reactions." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): e13579-e13579. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e13579.
Full textAbstract:
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.
9
Osahon, P. T., C. I. Chukwu, and C. C. Chukwu. "Prescription Pattern in the Eye Clinic of a Tertiary Health Facility in South-East Nigeria." Journal of Basic and Social Pharmacy Research 1, no. 5 (2020): 46–52. http://dx.doi.org/10.52968/27459928.
Full textAbstract:
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.
10
Zou, Min, Yves Barmaz, Melissa Preovolos, Leszek Popko, and Timothé Ménard. "Using Statistical Modeling for Enhanced and Flexible Pharmacovigilance Audit Risk Assessment and Planning." Therapeutic Innovation & Regulatory Science 55, no. 1 (August 17, 2020): 190–96. http://dx.doi.org/10.1007/s43441-020-00205-4.
Full textAbstract:
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.
11
Santoyo-Fexas, L., R. A. Uriarte Botello, C. V. Solis, B. R. Vázquez Fuentes, C. M. Skinner Taylor, I. D. J. Hernandez-Galarza, M. Eguia Bernal, and D. Á. Galarza-Delgado. "AB1291-HPR IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR ISSUING PRESCRIPTIONS IN PATIENTS WITH RHEUMATIC DISEASES." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1935.1–1936. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2218.
Full textAbstract:
Background:Pharmacovigilance is the science and activities related to detection, evaluation, understanding and prevention of adverse effects of medications or any other health problem related to them. (1)Within the scope of the pharmacovigilance study, following domains are included: adverse drug reaction, interaction between medications, counterfeit or inferior quality medications, lack of efficacy of medications, misuse or abuse of medications and medication errors (ME). (2)ME is any preventable incident that can cause harm to the patient or lead to improper use of medications when they are under the control of healthcare professionals or the patient. (3)Objectives:To determine the frequency of ME in the prescriptions among rheumatology outpatient’s clinic.Methods:Prospective observational study.Frequency of ME was sought by a randomized review of the prescriptions from rheumatology outpatient’s clinic of the University Hospital “Dr. José Eleuterio González” before and after the implementation of an electronic medical prescription system (REPAIR®) (January 2018-December 2019)REPAIR® displays an automated menu with the stages of the medical prescription: Name, presentation and dosage of the medicine and duration of the treatment. Figure 1. Once the review began, semiannual reports were made to the doctors involved in which frequency of errors and the stage of medical prescription with highest incidence of ME were reported.Figure 1Example image displayed by REPAIR®Descriptive statistics were performed, reporting frequencies and percentages.Results:A total of 1599 medical prescriptions were evaluated. The number of prescriptions with ME was 196 (12.2%). Table 1Table 1General description about errors in medical prescriptionsPrescriptions evaluated1599Prescription with ME n (%)196 (12.2%)Medications evaluated n10 413Medications with ME n (%)907(8.7%)Average medications per prescription6.4Average medications with ME per prescription0.78Prescription Stage Name of the drug n (%)2/10 413 (0.01%) Medication presentation n (%)77/ 10 413 (0.7%) Dose of the drug n (%)0/10 413 (0%) Duration of prescription n (%)725/10 413 (6.9%)The incidence of ME decreased, at beginning of the study incidence was reported 31.6%, and at the end were 1.5%. Graph 1The percentage of medications with ME also decreased from 17.2% to 0.8% at the end of the study. Table 2Table 2Errors in prescriptions per semesterJanuary-June 2018July-December 2018January-June 2019July-December 2019Prescriptions evaluated n321411407460Prescriptions with ME n (%)73 (31.6%)93 (22.6%)23 (5.6%)7 (1.5%)Medications evaluated n2126278426802823Medications with ME n (%)367 (17.2%)469 (16.8%)36 (1.7%)35 (0.8%)Average medications per prescription evaluated6.66.76.26.4Average medications per prescription evaluated1.1461.1430.0820.081Prescription Stage n (%) Name1/367(0.2%)1/469 (0.2%)00 Presentation37/367 (10%)37/469 (7.8%)1/36 (2.7%)2/35 (5.7%) Dose0000 Duration290/367 (89%)367/469 (88.2%)35/36 (97.2%)33/35 (94.2%)Conclusion:Decrease in the incidence of ME in rheumatology consultation is important because outcome of the patients depends significantly on treatment adherence. This study results shows that through the application of an electronic prescription system, it is possible to reduce the incidence of ME in rheumatology consultation.References:[1]Jeetu G, Anusha G. Pharmacovigilance: a worldwide master key for drug safety monitoring. J Young Pharm. 2010;2(3):315-20.[2]Organization WH. WHO pharmacovigilance indicators: a practical manual for the assessment of pharmacovigilance systems. 2015.[3]Elden NM, Ismail A. The Importance of Medication Errors Reporting in Improving the Quality of Clinical Care Services. Glob J Health Sci. 2016;8(8):54510.Graph 1Disclosure of Interests:None declared
12
Pagotto, Caroline, Fabiana Varallo, and Patrícia Mastroianni. "IMPACT OF EDUCATIONAL INTERVENTIONS ON ADVERSE DRUG EVENTS REPORTING." International Journal of Technology Assessment in Health Care 29, no. 4 (October 2013): 410–17. http://dx.doi.org/10.1017/s0266462313000457.
Full textAbstract:
Introduction: Spontaneous adverse drug events (ADE) reporting is the main source of data for assessing the risk/benefit of drugs available in the pharmaceutical market. However, its major limitation is underreporting, which hinders and delays the signal detection by Pharmacovigilance (PhV).Objectives: To identify the techniques of educational intervention (EI) for promotion of PhV by health professionals and to assess their impact.Methods: A systematic review was performed in the PUBMED, PAHO, LILACS and EMBASE databases, from November/2011 to January/2012, updated in March/2013. The strategy search included the use of health descriptors and a manual search in the references cited by selected papers.Results: 101 articles were identified, of which 16 met the inclusion criteria. Most of these studies (10) were conducted in European hospitals and physicians were the health professionals subjected to most EI (12), these studies lasted from one month to two years. EI with multifaceted techniques raised the absolute number, the rate of reporting related to adverse drug reactions (ADR), technical defects of health technologies, and also promoted an improvement in the quality of reports, since there was increased reporting of ADR classified as serious, unexpected, related to new drugs and with high degree of causality.Conclusion: Multifaceted educational interventions for multidisciplinary health teams working at all healthcare levels, with sufficient duration to reach all professionals who act in the institution, including issues related to medication errors and therapeutic ineffectiveness, must be validated, with the aim of standardizing the Good Practice of PhV and improve drug safety indicators.
13
Karsi, Redouane, Mounia Zaim, and Jamila El Alami. "Leveraging Pre-Trained Contextualized Word Embeddings to Enhance Sentiment Classification of Drug Reviews." Revue d'Intelligence Artificielle 35, no. 4 (August 31, 2021): 307–14. http://dx.doi.org/10.18280/ria.350405.
Full textAbstract:
Traditionally, pharmacovigilance data are collected during clinical trials on a small sample of patients and are therefore insufficient to adequately assess drugs. Nowadays, consumers use online drug forums to share their opinions and experiences about medication. These feedbacks, which are widely available on the web, are automatically analyzed to extract relevant information for decision-making. Currently, sentiment analysis methods are being put forward to leverage consumers' opinions and produce useful drug monitoring indicators. However, these methods' effectiveness depends on the quality of word representation, which presents a real challenge because the information contained in user reviews is noisy and very subjective. Over time, several sentiment classification problems use machine learning methods based on the traditional bag of words model, sometimes enhanced with lexical resources. In recent years, word embedding models have significantly improved classification performance due to their ability to capture words' syntactic and semantic properties. Unfortunately, these latter models are weak in sentiment classification tasks because they are unable to encode sentiment information in the word representation. Indeed, two words with opposite polarities can have close word embeddings as they appear together in the same context. To overcome this drawback, some studies have proposed refining pre-trained word embeddings with lexical resources or learning word embeddings using training data. However, these models depend on external resources and are complex to implement. This work proposes a deep contextual word embeddings model called ELMo that inherently captures the sentiment information by providing separate vectors for words with opposite polarities. Different variants of our proposed model are compared with a benchmark of pre-trained word embeddings models using SVM classifier trained on Drug Review Dataset. Experimental results show that ELMo embeddings improve classification performance in sentiment analysis tasks on the pharmaceutical domain.
14
Sende, J., E. Aaron, P. Bruge, S. Schvann, X. Combes, A. Margenet, and P. Duvaldestin. "189 - Pharmacovigilance : des indications de déclaration méconnues." Journal Européen des Urgences 17 (March 2004): 76. http://dx.doi.org/10.1016/s0993-9857(04)97199-3.
Full text
15
Sansom, Lloyd. "Pharmacists, Pharmacovigilance, Unapproved Indications and the TGA." Journal of Pharmacy Practice and Research 40, no. 2 (June 2010): 88–89. http://dx.doi.org/10.1002/j.2055-2335.2010.tb00509.x.
Full text
16
Gröner, Albrecht, Ye Jian, Pendrak Inna, and Cristina Solomon. "Safety of fibrinogen concentrate: analysis of more than 27 years of pharmacovigilance data." Thrombosis and Haemostasis 113, no. 04 (July 2015): 759–71. http://dx.doi.org/10.1160/th14-06-0514.
Full textAbstract:
SummaryFibrinogen concentrate use as a haemostatic agent has been increasingly explored. This study evaluates spontaneous reports of potential adverse drug reactions (ADRs) that occurred during postmarketing pharmacovigilance of Haemocomplettan P/RiaSTAP, and reviews published safety data. This descriptive study analysed postmarketing safety reports recorded in the CSL Behring pharmacovigilance database from January 1986 to December 2013. A literature review of clinical studies published during the same period was performed. Commercial data indicated that 2,611,294 g of fibrinogen concentrate were distributed over the pharmacovigilance period, main-contribonding to 652,824 standard doses of 4 g each, across a range of clinical settings and indications. A total of 383 ADRs in 106 cases were reported (approximately 1 per 24,600 g or 6,200 standard doses). Events of special interest included possible hypersensitivity reactions in 20 cases (1 per 130,600 g or 32,600 doses), possible thromboembolic events in 28 cases (1 per 93,300 g or 23,300 doses), and suspected virus transmission in 21 cases (1 per 124,300 g or 31,000 doses). One virus transmission case could not be analysed due to insufficient data; for all other cases, a causal relationship was assessed as unlikely due to negative polymerase chain reaction tests and/or alternative explanations. The published literature revealed a similar safety profile. In conclusion, underreporting of ADRs is a known limitation of pharmacovigilance. However, the present assessment indicates that fibrinogen concentrate is administered across a range of indications, with few ADRs and a low thromboembolic event rate. Overall, fibrinogen concentrate showed a promising safety profile.Institution to which work should be attributed: CSL Behring, Marburg, Germany.
17
Freitas Leal, Lisiane, and Daniel Marques Mota. "Thalidomide surveillance and pharmacovigilance in Brazil – an overview." Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia 9, no. 2 (May 31, 2021): 14–20. http://dx.doi.org/10.22239/2317-269x.01557.
Full textAbstract:
Introduction:The thalidomide is probably the best-known teratogenic drug and still results in cases of severe physical deformities in children born in Brazil. Objective:To present the overall context of surveillance and pharmacovigilance of thalidomide in Brazil. Method:This article presents a narrative review of current literature concerning thalidomide regulation, policies, and pharmacovigilance in Brazil. Results:New cases of congenital abnormalities whose phenotype is compatible with thalidomide embryopathy were identified in the last ten years, while the approval of thalidomide for new indications was recently updated. The mechanisms of diagnosing thalidomide embryopathy are complex, remaining the challenge in distinguishing this condition from other congenital abnormalities. The increasing number of thalidomide users in Brazil is correlated with the occurrence of embryopathy and the real extension of the rationality of its use is largely unknown. Additionally, our pharmacovigilance and surveillance systems are predominantly based on voluntary reports, issues that remains over the years. Conclusions:The policies have improved over the years to prevent the fetus from being exposed to thalidomide, and current regulation establishes rules for controlling its distribution, prescription, dispensation, and use. Brazilian surveillance system is manual and pharmacovigilance is supported by voluntary reports. The failure of the system to properly control the thalidomide use and its effects might lead to serious consequences to the community; therefore, this subject deserves constant attention.
18
Suwała, Justyna, Marta Oleś, and Anna Wiela-Hojeńska. "Adverse effects of venlafaxine therapy and risk factors for their occurrence." Pharmacotherapy in Psychiatry and Neurology 34, no. 4 (January 8, 2019): 285–304. http://dx.doi.org/10.33450/fpn.2019.01.003.
Full textAbstract:
Pharmacovigilance is an important aspect of depression treatment, considering that 40–90% of patients experience side effects of antidepressant use. This paper discusses the issues of optimising the use of venlafaxine, including its pharmacodynamic and pharmacokinetic properties, indications, adverse effects and risk factors for their occurrence, such as co-morbidities or genetic polymorphisms and interactions with other drugs.
19
Moriarty, Frank, Shegufta Razzaque, Ronald McDowell, and Tom Fahey. "Prescribing Variation in General Practices in England Following a Direct Healthcare Professional Communication on Mirabegron." Journal of Clinical Medicine 7, no. 10 (October 3, 2018): 320. http://dx.doi.org/10.3390/jcm7100320.
Full textAbstract:
Introduction: Pharmacovigilance may detect safety issues after marketing of medications, and this can result in regulatory action such as direct healthcare professional communications (DHPC). DHPC can be effective in changing prescribing behaviour, however the extent to which prescribers vary in their response to DHPC is unknown. This study aims to explore changes in prescribing and prescribing variation among general practitioner (GP) practices following a DHPC on the safety of mirabegron, a medication to treat overactive bladder (OAB). Methods: This is an interrupted time series study of English GP practices from 2014–2017. National Health Service (NHS) Digital provided monthly statistics on aggregate practice-level prescribing and practice characteristics (practice staff and registered patient profiles, Quality and Outcomes Framework indicators, and deprivation of the practice area). The primary outcome was monthly mirabegron prescriptions as a percentage of all OAB drug prescriptions and we assessed the change following a DHPC issued by the European Medicines Agency in September 2015. The DHPC stated mirabegron use was contraindicated with severe uncontrolled hypertension and cautioned with hypertension. Variation between practices in mirabegron prescribing before and after the DHPC was assessed using the systematic component of variation (SCV). Multilevel segmented regression with random effects quantified the change in level and trend of prescribing after the DHPC. Practice characteristics were assessed for their association with a reduction in prescribing following the DHPC. Results: This study included 7408 practices. During September 2015, 88.9% of practices prescribed mirabegron and mirabegron comprised a mean of 8.2% (SD 6.8) of OAB prescriptions. Variation between practices was classified as very high and the median SCV did not change significantly (p = 0.11) in the six months after the September 2015 DHPC (12.4) compared to before (11.6). Before the DHPC, the share of mirabegron over all OAB drug prescriptions increased by 0.294 (95% confidence interval (CI), 0.287, 0.301) percentage points per month. There was no significant change in the month immediately after the DHPC (−0.023, 95% CI −0.105 to 0.058), however there was a significant reduction in trend (−0.036, 95% CI −0.049 to −0.023). Higher numbers of registered patients, patients aged ≥65 years, and practice area deprivation were associated with having a significant decrease in level and slope of mirabegron prescribing post-DHPC. Conclusion: Variation in mirabegron prescribing was high over the study period and did not change substantively following the DHPC. There was no immediate prescribing change post-DHPC, although the monthly growth did slow. Knowledge of the degree of variation in and determinants of response to safety communications may allow those that do not change prescribing habits to be provided with additional support.
20
Denny, J. C., Q. Chen, H. Nian, A. Spickard, S. T. Rosenbloom, R. A. Miller, and J. C. Smith. "Lessons Learned from Developing a Drug Evidence Base to Support Pharmacovigilance." Applied Clinical Informatics 04, no. 04 (2013): 596–617. http://dx.doi.org/10.4338/aci-2013-08-ra-0062.
Full textAbstract:
Summary Objectives: This work identified challenges associated with extraction and representation of medication-related information from publicly available electronic sources. Methods: We gained direct observational experience through creating and evaluating the Drug Evidence Base (DEB), a repository of drug indications and adverse effects (ADEs), and supplemented this through literature review. We extracted DEB content from the National Drug File Reference Terminology, from aggregated MEDLINE co-occurrence data, and from the National Library of Medicine’s DailyMed. To understand better the similarities, differences and problems with the content of DEB and the SIDER Side Effect Resource, and Vanderbilt’s MEDI Indication Resource, we carried out statistical evaluations and human expert reviews. Results: While DEB, SIDER, and MEDI often agreed on medication indications and side effects, cross-system shortcomings limit their current utility. The drug information resources we evaluated frequently employed multiple, disparate vaguely related UMLS concepts to represent a single specific clinical drug indication or adverse effect. Thus, evaluations comparing drug-indication and drug-ADE coverage for such resources will encounter substantial numbers of false negative and false positive matches. Furthermore, our review found that many indication and ADE relationships are too complex – logically and temporally – to represent within existing systems. Conclusion: To enhance applicability and utility, future drug information systems deriving indications and ADEs from public resources must represent clinical concepts uniformly and as precisely as possible. Future systems must also better represent the inherent complexity of indications and ADEs. Citation: Smith JC, Denny JC, Chen Q, Nian H, Spickard III A, Rosenbloom ST, Miller RA. Lessons learned from developing a drug evidence base to support pharmacovigilance. Appl Clin Inf 2013; 4: 596–617http://dx.doi.org/10.4338/ACI-2013-08-RA-0062
21
Vallejo-Yagüe, E., S. Weiler, and A. M. Burden. "OP0237 THROMBOEMBOLIC SAFETY PROFILE OF TOFACITINIB AND BARICITINIB: AN ANALYSIS OF WHO VIGIBASE." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 150.1–150. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2823.
Full textAbstract:
Background:The Janus Kinase (JAK) inhibitors tofacitinib and baricitinib are new targeted treatments for rheumatoid arthritis. Recent concerns regarding the risk of thrombosis have led to warnings by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA)1,2.Objectives:To examine the safety reporting of tofacitinib and baricitinib, with focus on thromboembolic events.Methods:Individual case safety reports (ICSRs) for tofacitinib and baricitinib were retrieved from the World Health Organization (WHO) global database (VigiBase) in April 2019. The primary outcomes were deep vein thrombosis (DVT) and pulmonary thrombosis (PT) or pulmonary embolism (PE). A disproportionality analysis was conducted by estimating the reporting odds ratio (ROR) and 95% confidence intervals (CIs) to compare the observed versus expected reporting ratio of DVT or PT|PE for tofacitinib or baricitinib. The ROR were calculated worldwide and stratifying by reporting from Europe or the US. In a secondary analysis, further thrombotic-related outcomes were investigated.Results:In both tofacitinib (n=40,017) and baricitinib (n=2,138) ICSRs, patients with reported DVT or PT|PE were older and had higher reporting of pro-thrombotic medications (e.g., contraceptives) or indicators of thromboembolic risk (i.e., antithrombotic treatment). The use of tofacitinib was associated with a significant increased reporting for DVT (ROR: 2.37 95% CI 1.23-4.56) and PT|PE (ROR 2.38 95% CI 1.45-3.89) in Europe. In the US, tofacitinib was only associated with an elevated reporting of PT (ROR: 2.05 % CI 1.45-2.90). Baricitinib was associated with a 3-fold increased risk of reporting for DVT (ROR: 3.47 95% CI 2.18-5.52) or PT|PE (ROR: 3.44 95% CI 2.43-4.88) in Europe, which accounted for 97% of all baricitinib ICSRs. Secondary thrombotic-related outcomes were poorly reported overall in VigiBase.Conclusion:This study supports the cautious use of JAK inhibitors in patients with rheumatoid arthritis who have a high thrombotic risk profile. Moreover, a potential class effect of JAK inhibitors cannot be ruled out.References:[1]FDA Drug Safety Communication. Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate. Food and Drug Administration (FDA)http://www.fda.gov/drugs/drug-safety-and-availability/safety-trial-finds-risk-blood-clots-lungs-and-death-higher-dose-tofacitinib-xeljanz-xeljanz-xr(2019).[2]EMA confirms Xeljanz to be used with caution in patients at high risk of blood clots. EMA/608520/2019.https://www.ema.europa.eu/en/documents/referral/xeljanz-article-20-procedure-ema-confirms-xeljanz-be-used-caution-patients-high-risk-blood-clots_en.pdf(2019).Acknowledgments:We are thankful to every pharmacovigilance centre and contributor to the WHO Programme for International Drug Monitoring and VigiBase.While the authors used data from the VigiBase, the WHO global database of ICSRs as a source of information, the conclusions do not represent the opinion of the Uppsala Monitoring Centre (UMC) or the WHO.Disclosure of Interests:Enriqueta Vallejo-Yagüe Employee of: Synovo GmbH 2012-2018 (not related to this abstract), Stefan Weiler Consultant of: Gedeon-Richter for drug safety 2017 (not related to this abstract), Andrea Michelle Burden: None declared
22
Hilmi, Marc, Stéphane Ederhy, Xavier Waintraub, Christian Funck-Brentano, Ariel Cohen, Aurore Vozy, Bénédicte Lebrun-Vignes, Javid Moslehi, Lee S. Nguyen, and Joe-Elie Salem. "Cardiotoxicity Associated with Gemcitabine: Literature Review and a Pharmacovigilance Study." Pharmaceuticals 13, no. 10 (October 21, 2020): 325. http://dx.doi.org/10.3390/ph13100325.
Full textAbstract:
Background: Gemcitabine is a nucleoside analog, widely used either alone or in combination, for the treatment of multiple cancers. However, gemcitabine may also be associated with cardiovascular adverse-drug-reactions (CV-ADR). Methods: First, we searched for all cases of cardiotoxicity associated with gemcitabine, published in MEDLINE on 30 May 2019. Then, we used VigiBase, the World Health Organization’s global database of individual case safety reports, to compare CV-ADR reporting associated with gemcitabine against the full database between inception and 1 April 2019. We used the information component (IC), an indicator value for disproportionate Bayesian reporting. A positive lower end of the 95% credibility interval for the IC (IC025) ≥ 0, is deemed significant. Results: In VigiBase, 46,898 reports were associated with gemcitabine on a total of 18,908,940 in the full database. Gemcitabine was associated with higher reporting for myocardial ischemia (MI, n: 119), pericardial diseases (n: 164), supraventricular arrhythmias (SVA, n: 308) and heart failure (HF, n: 484) versus full database with IC025 ranging between 0.40 and 2.81. CV-ADR were associated with cardiovascular death in up to 17% of cases. Conclusion: Treatment with gemcitabine is associated with potentially lethal CV-ADRs, including MI, pericardial diseases, SVA and HF. These events should be considered in patient care and clinical trial design.
23
Milone, Gustavo, Francisco Fernandez, Maria Ines Penna, and Roberto Gomez. "Pharmacovigilance of a Rituximab Biosimilar (Novex) in Argentina." Blood 128, no. 22 (December 2, 2016): 3568. http://dx.doi.org/10.1182/blood.v128.22.3568.3568.
Full textAbstract:
Abstract INTRODUCTION Novex is a rituximab biosimilar approved in Argentina. From January 2015 to June 2016 as part of the Risk Management Plan approved by ANMAT, every treatment detected was recorded and a follow up was implemented in order to obtain safety information. The aim of this communication is to present the information gathered during this pharmacovigilance program. MATERIALS AND METHODS All treatments with at least 1 follow up point were selected and reviewed. Treatment duration until last follow up checkpoint or date of treatment finalization was recorded. We summarized demographic data (age, gender), indication distribution, treatment exposition (duration expressed in days and number of cycles received), adverse event frequency (cumulative incidence and incidence density) and distribution. RESULTS We collected 345 treatment notifications with at least 1 follow up point. Gender distribution: 53.2 % of patients were male patients. Age range was 10 to 90 years old, with a mean of 63.9 years. The indications distribution is summarized in table 1. More than 90% of them were hematological. Average treatment duration was of 235 days with a median duration of 210 days (IQR = 152 - 311). Mean number of cycles 5.5; range (1-12).During the reported period a total of 12 Individual Case Safety Reports (ICSR) were received. This represents a cumulative incidence of 3.5 %, an incidence density of 0.015 ICSR notifications per 100 days of treatment and 0.99 per 100 administered cycles. These 12 ICSR totalized 14 different diagnoses. Of them, the most frequent was Acute Infusion Related Reaction (AIRR), as expected. All AE but 1 were classified as serious (SAE) because they had at least 1 manifestation that prolonged hospitalization or endangered life. As expected, the most frequent AE notified was AIRR (5 cases), followed by cardiovascular manifestations (2 arrhythmia, 1 cardiac failure and 1 ischemic stroke), infections (1 pneumonia, 1 progressive multifocal leukoencephalopathy), neurologic (1 paresthesia), cytopenias (1 pancytopenia) and cutaneous (1 bullous dermatitis). Most of the acute manifestations occurred within the 2 initial infusions of Rituximab, as described. CONCLUSION The observed AE frequency and distribution was consistent with product specifications. No AE notified were unlisted or were notified with greater frequency than expected. Treatments registry resulted in a suitable way to detect AE that complements spontaneous reporting. Disclosures Fernandez: Laboratorio ELEA S.A.C.I.F y A: Employment. Penna:Laboratorio ELEA S.A.C.I.F y A: Employment. Gomez:Laboratorio ELEA S.A.C.I.F y A: Employment.
24
Borg, John-Joseph, Yolanda Elias Gramajo, Andrea Laslop, Robin Thorpe, and Jian Wang. "3rd Colombian educational workshop on regulatory assessment of biosimilars 2019 – Report." Generics and Biosimilars Initiative Journal 9, no. 3 (September 15, 2020): 132–44. http://dx.doi.org/10.5639/gabij.2020.0903.022.
Full textAbstract:
Introduction: Biosimilars have the potential to improve access to medicines for many across the globe. However, work is required to ensure adequate regulation, pharmacovigilance and education about biosimilars. Colombia implemented biosimilars regulation in 2017 and a 3rd Colombian Educational Workshop was organized by GaBI and the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in 2019 to follow up on progress and provide a forum for further discussion. Methods: The 3rd Colombian Educational Workshop on Regulatory Assessment was held in Bogotá, Colombia on 30 April 2019. The format included expert speaker presentations, a panel discussion, Q&A sessions and case study workgroup discussions. Participants included regulators, clinicians, pharmacists, academics and healthcare professionals from Colombia who are involved in biological/ biosimilar medicines evaluation, and expert speakers from Canada, Europe and the US. Results: Presentations and topics of discussion included the current status of biosimilars regulation in Colombia, how to carry out a quality assessment of a biological/biosimilar, pharmacological and clinical studies, and extrapolation of indications. Conclusion: The meeting helped to clarify many regulatory concepts and concerns, and highlighted Colombia’s initial successes since the implementation of its regulatory guidelines. In addition, the meeting acted as a forum to exchange knowledge on best practice, and to discuss pharmacovigilance and the future plans for education regarding biosimilars in Colombia. Several key action points were concluded following the discussions.
25
Endrikat, Jan, and Nicoletta Anzalone. "Gadobutrol in India—A Comprehensive Review of Safety and Efficacy." Magnetic Resonance Insights 10 (January 1, 2017): 1178623X1773004. http://dx.doi.org/10.1177/1178623x17730048.
Full textAbstract:
Gadobutrol is a gadolinium (Gd)-based contrast agent for magnetic resonance imaging (MRI). In India, gadobutrol is approved for MRI of the central nervous system (CNS), liver, kidneys, breast and for MR angiography for patients 2 years and older. The standard dose for all age groups is 0.1 mmol/kg body weight. The safety profile has been demonstrated in 42 clinical phase 2 to 4 studies (>6800 patients), 7 observational studies, and by assessing pharmacovigilance data of 29 million applications. Furthermore, studies in children, adults, and elderly and in patients with impaired liver or kidney function did not show any increased adverse event rate. Diagnostic efficacy was demonstrated in numerous studies and various indications, such as diseases of the CNS, peripheral and supra-aortic vessels, kidneys, liver, and breast.
26
Murray, Hugh, Ee Laine Tay, Sarah Dinh, Helen Matthews, Alan Street, and Justin T. Denholm. "The Use of Fluoroquinolones for Tuberculosis in Victoria between 2011 and 2016." Tuberculosis Research and Treatment 2018 (July 2, 2018): 1–6. http://dx.doi.org/10.1155/2018/6860479.
Full textAbstract:
Setting. Tuberculosis treatment requires long regimens with multiple antibiotics and is complicated by antibiotic resistance and intolerance. Fluoroquinolones were introduced for the treatment of multidrug resistant TB and have become a vital part of therapy. Objective. Reviewing the indications for fluoroquinolones use in the treatment of active TB in Victoria, Australia. Design. This was a retrospective case-control study of Victorian patients prescribed fluoroquinolones for active tuberculosis, from January 2011 to December 2016. Indications for fluoroquinolone use were extracted from an existing public health database. Results. There were 2268 patients notified to have tuberculosis in Victoria between 2011 and 2016, 276 (12.2%) of whom received a fluoroquinolone. The indications were substitution when intolerance was present (33.3%) or anticipated (21.0%), proven drug resistance (22.5%), suspected drug resistance (13.0%), and site of disease (10.1%). Where fluoroquinolones were prescribed for suspected drug resistance, only a minority of isolates (13%) had resistance confirmed. Conclusion. Fluoroquinolones were most commonly used as replacement for first-line therapy related to adverse effects, when either present or anticipated. Where fluoroquinolones were prescribed for suspected drug resistance, only a minority of isolates ultimately had resistance confirmed. These findings reinforce the importance of fluoroquinolones in TB therapy and the need for ongoing pharmacovigilance to ensure appropriate use.
27
Thibault, L., and L. Ruesche. "Hypomanie et baclofène : à propos de trois cas cliniques." European Psychiatry 29, S3 (November 2014): 532. http://dx.doi.org/10.1016/j.eurpsy.2014.09.390.
Full textAbstract:
IntroductionLe traitement de l’alcoolo-dépendance représente un enjeu majeur de santé publique en France. Le baclofène, myorelaxant d’action centrale, agoniste du récepteur GABA-B, dispose depuis 1974 d’une AMM pour le traitement de la spasticité musculaire. Devant une utilisation croissante du baclofène hors-AMM dans le traitement de l’alcoolo-dépendance, l’ANSM a organisé dès 2011 un suivi national de pharmacovigilance. Le RCP a été mis à jour le 27/11/13, introduisant de nouvelles précautions d’emploi, dont les troubles psychiatriques sévères, pouvant favoriser des dépressions majeures avec suicides et une sévérité accrue des effets indésirables. Une RTU, octroyée le 14/03/2014 par l’ANSM, permet désormais la prescription de baclofène dans deux indications spécifiées, après échec des autres traitements disponibles.Objectifs et méthodesRapporter les effets indésirables liés au baclofène dans le traitement de l’alcoolo-dépendance, conformément aux recommandations de l’ANSM, à travers l’étude de trois cas d’hypomanie, survenus à de faibles doses, chez des patients ayant des comorbidités psychiatriques, et tenter, au regard de la littérature, une approche analytique de ces données.RésultatsCes épisodes, obligeant l’arrêt du traitement, ont évolué vers une guérison sans séquelle. Un seul cas est survenu dans le cadre de la RTU, objet d’une déclaration d’effet indésirable : le signalement d’hypomanie au CRPV a été considéré comme effet indésirable grave, non mentionné dans le RCP. La présence constante d’un antidépresseur interroge sur les interactions : leur utilisation concomitante, signalée comme association à prendre en compte, devrait-elle être déconseillée, par risque de virage hypomaniaque ?ConclusionCes observations cliniques renforcent la question de l’efficacité du baclofène dans le traitement de l’alcoolo-dépendance en présence de pathologies psychiatriques associées par risque important d’effets indésirables graves. Le protocole de suivi de la RTU offre un cadre sécurisant et prometteur dans le système de pharmacovigilance. Les résultats d’études randomisées sont attendus prochainement.
28
Xue, Mengzhu, Shoude Zhang, Chaoqian Cai, Xiaojuan Yu, Lei Shan, Xiaofeng Liu, Weidong Zhang, and Honglin Li. "Predicting the Drug Safety for Traditional Chinese Medicine through a Comparative Analysis of Withdrawn Drugs Using Pharmacological Network." Evidence-Based Complementary and Alternative Medicine 2013 (2013): 1–11. http://dx.doi.org/10.1155/2013/256782.
Full textAbstract:
As the major issue to limit the use of drugs, drug safety leads to the attrition or failure in clinical trials of drugs. Therefore, it would be more efficient to minimize therapeutic risks if it could be predicted before large-scale clinical trials. Here, we integrated a network topology analysis with cheminformatics measurements on drug information from the DrugBank database to detect the discrepancies between approved drugs and withdrawn drugs and give drug safety indications. Thus, 47 approved drugs were unfolded with higher similarity measurements to withdrawn ones by the same target and confirmed to be already withdrawn or discontinued in certain countries or regions in subsequent investigations. Accordingly, with the 2D chemical fingerprint similarity calculation as a medium, the method was applied to predict pharmacovigilance for natural products from an in-house traditional Chinese medicine (TCM) database. Among them, Silibinin was highlighted for the high similarity to the withdrawn drug Plicamycin although it was regarded as a promising drug candidate with a lower toxicity in existing reports. In summary, the network approach integrated with cheminformatics could provide drug safety indications effectively, especially for compounds with unknown targets or mechanisms like natural products. It would be helpful for drug safety surveillance in all phases of drug development.
29
Campillo, J., C. Eiden, M. Boussinesq, S. Pion, J. Faillie, and C. Chesnais. "Les effets indésirables associés au lévamisole varient en fonction de ses indications et de son mésusage : une étude systématique de pharmacovigilance." Infectious Diseases Now 51, no. 5 (August 2021): S111. http://dx.doi.org/10.1016/j.idnow.2021.06.251.
Full text
30
Wörmann, Bernhard, and Marianne Sinn. "Position of Scientific Oncological Societies Towards Biosimilar Antibodies." Breast Care 14, no. 1 (2019): 5–8. http://dx.doi.org/10.1159/000495145.
Full textAbstract:
First biosimilars of monoclonal antibodies have recently been approved in oncology. Biosimilars enable economic competition, alleviate the financial burden for insurances, and may facilitate access to these drugs in low-income countries. Biosimilars are not completely identical to the original drug. The approval of biosimilars is only partially based on results of randomized clinical studies. In the introduction phase of new biosimilars, this can lead to uncertainties for patients and physicians. Based on the current clinical data and experiences, biosimilars of monoclonal antibodies in oncology show no significant differences in pharmacokinetics, efficacy, and safety in comparison to the patented originals. Scientific medical societies recommend the use of biosimilar monoclonal antibodies and support switching in long-term treatments. However, the use of biosimilars for off-label indications requires additional attention towards efficacy and safety. Active counselling of the patient by the treating physician is the most important step in the informed consent process, especially when switching from an original to a biosimilar. Careful documentation of the prescribed drug and enhanced pharmacovigilance are recommended for the use of biosimilars.
31
Pallivalapila, Abdul Rouf, Isaac A. Babarinsa, Mariam Al-Baloushi, Ahmed Moursi, Arabo Bayo, Binny Thomas, and Mahmoud G. Mahmoud Mohd. "Pharmaco-vigilance of oral MethylErgometrine prescriptions for delayed and secondary postpartum haemorrhage." Journal of Perinatal Medicine 48, no. 8 (October 25, 2020): 853–55. http://dx.doi.org/10.1515/jpm-2020-0128.
Full textAbstract:
AbstractObjectivesThe objectives of this study were to quantify the prescription of oral methergin tablets in a busy Women’s Hospital, assess the stated indications for such prescription and highlight the issues and safety profile of Methergin use especially in the postpartum patient.MethodsReview of prescription data for oral Methergin and the corresponding annual figures on primary and secondary postpartum hemorrhage.ResultsOver a period of 5 years, oral Methergin prescriptions for delayed and secondary postpartum hemorrhage constituted less than 1% of the overall prescription in Obstetrics and Gynaecology, which ranged between 1214 and 2085 per year. The numbers were too few to ascertain any relationship with both types of postpartum hemorrhage. Although stated on the relevant Patient Information leaflet, no local or regional guideline on its use exist.ConclusionsSpecific and random trend monitoring of medications for continuing safety profile, risk benefit issues, or unapproved indication, may help in identifying, preventing and mitigating any medication safety matters. Clinical pharmacists in collaboration with physicians are well placed in conducting such pharmacovigilance activities to improve medication safety.
32
Romer, Tomasz E. "The Role of Recombinant Human Growth Hormone Biosimilars in the Management of Growth Disorders." European Endocrinology 05 (2009): 47. http://dx.doi.org/10.17925/ee.2009.05.00.47.
Full textAbstract:
Since ancient times plant and animal tissues have been used as medicines. In the 20th century growth hormone as a purified extraction from human pituitaries was still used to treat growth disorders. Since the genetic engineering of host cells became possible, a new generation of medicines obtained using recombinant DNA (rDNA) technology has emerged. These medicines have been named ‘biopharmaceuticals’. The first biopharmaceutical growth hormones were patented in the 1980s, so already over two decades of clinical experience support the development of a new, off-patent growth hormone preparation obtained by rDNA technology. The European Medicines Agency (EMEA) has put in place a centralised procedure for the approval of new biopharmaceuticals. This procedure includes testing comparability with a reference product and demands post-approval pharmacovigilance. Omnitrope® was the first off-patent recombinant human growth hormone (rhGH) approved on the basis of the biosimilar pathway; it underwent a very demanding approval procedure in 2006 and is now used for several indications in Europe, the US, Canada, Japan, Australia and other countries where it has received marketing approval.
33
Arnaud, Laurent, Philippe Mertz, Pierre-Edouard Gavand, Thierry Martin, François Chasset, Martine Tebacher-Alt, Aude Lambert, et al. "Drug-induced systemic lupus: revisiting the ever-changing spectrum of the disease using the WHO pharmacovigilance database." Annals of the Rheumatic Diseases 78, no. 4 (February 4, 2019): 504–8. http://dx.doi.org/10.1136/annrheumdis-2018-214598.
Full textAbstract:
ObjectiveDrug-induced lupus (DIL) is an idiosyncratic side effect of treatments in which symptoms overlap with those of systemic lupus erythematosus (SLE). The spectrum of DIL constantly evolves with that of the pharmacopoeia. Here, we used VigiBase, the WHO global individual case safety reports (ICSRs) database, to identify the main drugs associated with DIL.MethodsWe analysed all ICSRs classified as ‘systemic lupus erythematosus’ according to the Medical Dictionary for Drug Regulatory Activities term (preferred term level) in VigiBase. The drugs considered in the analysis were those not used to treat SLE, with a positive lower end of the 95% credibility interval for the information component (IC025) ≥0, an indicator value for disproportionate Bayesian reporting.ResultsA total of 12 166 DIL ICSRs were identified using VigiBase. From those, 8163 ICSRs reporting on 118 suspected drugs with IC025 ≥0 were extracted. The median age at DIL onset was 49 years and the female to male sex ratio was 4.3. The median delay between start of suspected treatment and DIL occurrence was 172 days. DIL was reported as serious adverse event in 55.4%. Among the 118 suspected drugs, 42 had not been previously reported in association with DIL. The drugs associated with the highest number of DIL cases were infliximab, adalimumab, etanercept, procainamide and hydralazine.ConclusionThis study enables the identification of 118 drugs associated with DIL. The list of suspected drugs may prove useful to physicians when confronted with potential DIL cases.Trial registration numberNCT03480529.
34
Otero-Lobato, M., S. Esslinger, S. Gabriel, M. Clark, P. Sheridan, and A. Geldhof. "SAT0117 TRIMESTER EXPOSURE AND PREGNANCY OUTCOMES IN WOMEN EXPOSED TO GOLIMUMAB – RESULTS FROM THE COMPANY PHARMACOVIGILANCE DATABASE." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 992.2–992. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2796.
Full textAbstract:
Background:Rheumatologic disorders and inflammatory bowel disease can affect women of childbearing potential. Golimumab (GLM) is approved for several rheumatologic indications and ulcerative colitis (UC).Objectives:To characterize pregnancy outcomes in patients treated with GLM, data obtained from maternal exposure to GLM are presented.Methods:This dataset includes individual patient cases reported to the manufacturer through 06 April 2019. Cases included in the analysis were medically confirmed cases of maternal exposures to GLM during pregnancy or within 3 months prior to conception, and a reported pregnancy outcome. Both prospectively reported (ie, pregnancy outcome not known when first reported) and retrospectively reported cases (ie, pregnancy outcome known when first reported) were included. Cases originated from various sources, including spontaneous reporting, clinical studies, and registries.Results:Two hundred eight pregnancy cases (131 rheumatologic indications; 43 UC; and 34 other) with 211 reported birth outcomes were identified. Of these 208 pregnancy cases, 119 were prospective and 89 were retrospective. Average maternal age was 31.9 years. Of the 119 prospectively reported pregnancy cases, 89 (74.8%) resulted in live births, 19 (16.0%) resulted in spontaneous abortion (of these, 42.1% (8/19) received GLM in combination with methotrexate [MTX]), 10 (8.4%) resulted in induced/elective abortion, and 1 (0.8%) resulted in ectopic pregnancy. Overall, 9 congenital anomalies were reported (2 prospective and 7 retrospective cases).For 183 of the 208 pregnancy cases with reported outcomes, the trimester of exposure to GLM was known. Among the 110 prospectively reported cases, 82 (74.5%) were exposed during trimester 0 or 1. Of these, 19 had concomitant exposure to MTX, with the following birth outcomes: 8 live births, 8 spontaneous abortions, 3 elective/induced abortions. Eighteen of the prospectively reported cases (16.4%) were exposed to GLM through trimesters 1-3 and all resulted in live births (none with congenital anomalies; 1 infant with exposure to GLM and MTX was born preterm).Conclusion:The rates of congenital malformations and spontaneous abortions were consistent with published background rates for the general population. Persistent exposure throughout pregnancy was rare. Limitations of this analysis include the lack of a direct comparison group, the variable amount of data available in the reports, and the possible bias towards reporting more negative outcomes in retrospective cases.Disclosure of Interests:Marijo Otero-Lobato Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Suzan Esslinger Shareholder of: Johnson & Johnson, Consultant of: Johnson & Johnson, Novartis, Eli Lilly and Sandoz, Employee of: Johnson & Johnson, Susan Gabriel Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Merck, GSK, Michael Clark Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Pamela Sheridan Shareholder of: Johnson & Johnson, Roche Pharmaceuticals, Employee of: Johnson & Johnson, Roche, Novartis, Bayer, Anja Geldhof Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson
35
Resende, Heloisa Magda, Paola Cardoso, Pedro Marassi, Maristela Seoanes Precivale, Alexandre Alcantara, Ana Carolina Cardoso, Lara Lopes Facó, Leandro Ladislau Alves, and Vivienne Carduz Castilho. "Extrapolation of indications and drug interchangeability as barriers to use trastuzumab-dkst biosimilar in Brazil." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): e13010-e13010. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e13010.
Full textAbstract:
e13010 Background: Brazil has a complex health-care system which comprises 76% of population in the public unified health system (SUS) and only 24% in private system. Even with most of the population in the public system low resources has been allocated SUS by the government compared with that in private system. Breast cancer (BC) is the more frequent malignant neoplasm in Brazilian women, including HER2 overexpression, and the most are treated in SUS. Although, the HER2 blockage benefits in overall survival have been demonstrated since 2005, the adjuvant and neoadjuvant HER2 blockage was included in SUS protocols only 2013 while the metastatic only 2018. Brazil and development countries have limited accesses to biological drugs and target therapies due to the high cost. The biosimilar technology would improve the patient access to these drugs, health-care savings with efficacy and safety. In 2017, Brazil has approved the first biosimilar in oncology, the anti-HER2 monoclonal antibody trastuzumab-dkst. Our aim is understanding the reasons that hampered the Brazilian oncologists changing practice about biosimilars. Methods: We submitted an on-line survey with 12 questions to 144 Brazilian oncologists which are registered in Brazilian Clinical Oncology Society from North, Northeast, Center east, Center west and Southeast regions in Brazil. The questions were about the anti-HER2 biosimilars knowledge, the manufacturing process, the costs, the biosimilars-based clinical trial, the drug efficacy and safety. Results: We observed that all responders have 9 years experienced oncologist with mean of care 15 patient with HER2 BC per month. In total, 95% of oncologist knows biosimilar definition and 96% assume prescribe biosimilars without doubts. However, 81% oncologists would prescribe biosimilars to all patients, 82% would interchanges and 63% would extrapolate the indication. Conclusions: This survey was conducted to understand the Brazilian oncologist knowledge about biosimilar. We demonstrated a high knowledge of biosimilar definition, however with high percentage indicated adherence barriers. The pharmacovigilance, clinical trials that support biosimilar approval and extrapolation concepts are the main aspects to be addressed. The opportunity of patient access with biosimilars is real and it is the oncologist’s duty to engage in medical education programs. This study could highlight a crucial need for greater strategies to educate physicians, to disseminate biosimilars and provide more informed decision making.
36
Chen, Xieling, Shan Wang, Yong Tang, and Tianyong Hao. "A bibliometric analysis of event detection in social media." Online Information Review 43, no. 1 (February 11, 2019): 29–52. http://dx.doi.org/10.1108/oir-03-2018-0068.
Full textAbstract:
Purpose The purpose of this paper is to explore the research status and development trend of the field of event detection in social media (ED in SM) through a bibliometric analysis of academic publications. Design/methodology/approach First, publication distributions are analyzed including the trends of publications and citations, subject distribution, predominant journals, affiliations, authors, etc. Second, an indicator of collaboration degree is used to measure scientific connective relations from different perspectives. A network analysis method is then applied to reveal scientific collaboration relations. Furthermore, based on keyword co-occurrence analysis, major research themes and their evolutions throughout time span are discovered. Finally, a network analysis method is applied to visualize the analysis results. Findings The area of ED in SM has received increasing attention and interest in academia with Computer Science and Engineering as two major research subjects. The USA and China contribute the most to the area development. Affiliations and authors tend to collaborate more with those within the same country. Among the 14 identified research themes, newly emerged themes such as Pharmacovigilance event detection are discovered. Originality/value This study is the first to comprehensively illustrate the research status of ED in SM by conducting a bibliometric analysis. Up-to-date findings are reported, which can help relevant researchers understand the research trend, seek scientific collaborators and optimize research topic choices.
37
Esslinger, S., M. Otero-Lobato, S. Gabriel, M. Clark, P. Sheridan, and A. Geldhof. "P599 Trimester exposure and pregnancy outcomes in women exposed to golimumab: Results from the company pharmacovigilance database." Journal of Crohn's and Colitis 14, Supplement_1 (January 2020): S500—S501. http://dx.doi.org/10.1093/ecco-jcc/jjz203.727.
Full textAbstract:
Abstract Background Rheumatologic disorders and inflammatory bowel disease can affect women of childbearing potential. Golimumab (GLM) is approved for several rheumatological indications and ulcerative colitis (UC). To characterise pregnancy outcomes in patients treated with GLM, data obtained from maternal exposure to GLM are presented. Methods These dataset includes individual patient cases reported to the manufacturer through 06 April 2019. Cases included in the analysis were medically confirmed cases of maternal exposures to GLM during pregnancy or within 3 months prior to conception, and a reported pregnancy outcome. Both prospectively reported (ie, pregnancy outcome not known when first reported) and retrospectively reported cases (ie, pregnancy outcome known when first reported) were included. Cases originated from various sources, including spontaneous reporting, clinical studies, and registries. Results Two hundred eight pregnancy cases (131 rheumatological; 43 UC; and 34 other) with 211 reported birth outcomes were identified. Three cases reported twin pregnancies. Of the 208 pregnancy cases, 119 were prospective and 89 were retrospective (Table 1). Average maternal age was 31.9 years. Of the 119 prospectively reported pregnancy cases, 89 (74.8%) resulted in live births, 19 (16.0%) resulted in spontaneous abortion (of these, 42.1% (8/19) received GLM in combination with methotrexate [MTX]), 10 (8.4%) resulted in induced/elective abortion, and 1 (0.8%) resulted in ectopic pregnancy. Overall, 9 congenital anomalies were reported (2 prospective/7 retrospective cases). For 183 of the 208 pregnancy cases with-reported outcomes, the trimester of exposure to GLM was known (Table 2). Among the 110 prospectively reported cases, 82 (74.5%) were exposed during trimester 0 or 1. Of these, 19 had concomitant exposure to MTX, with the following birth outcomes: 8 live births, 8 spontaneous abortions, 3 elective/induced abortions. Eighteen of the prospectively reported cases (16.4%) were exposed to GLM throughout pregnancy (first, second and third trimester) and all resulted in live births. Conclusion The rates of congenital malformations and spontaneous abortions were consistent with published background rates for the general population. Persistent exposure throughout pregnancy was rare, but not associated with apparent clinical sequelae. Limitations of this analysis include the lack of a direct comparison group, the variable amount of data available in the reports, and the possible bias towards reporting more negative outcomes in retrospective cases.
38
Druschky, Katrin, Stefan Bleich, Renate Grohmann, Katharina Burda, Helge Frieling, Thomas Hillemacher, Alexandra Neyazi, Susanne Stübner, and Sermin Toto. "Severe hair loss associated with psyc hotropic drugs in psychiatric inpatients—Data from an observational pharmacovigilance program in German-speaking countries." European Psychiatry 54 (August 5, 2018): 117–23. http://dx.doi.org/10.1016/j.eurpsy.2018.08.003.
Full textAbstract:
AbstractBackground:The study aimed to investigate severe hair loss related to psychotropic drugs (PDs) by using data from the drug safety programme Arzneimittelsicherheit in der Psychiatrie (AMSP).Methods:Data on PD utilization and reports of severe PD-related hair loss were collected in 83 psychiatric hospitals in Austria, Germany and Switzerland during the period 1993–2013.Results:Out of 432, 215 patients under surveillance, 404, 009 patients were treated with PDs for the main indications of depression, schizophrenic disorder, neurosis, mania, and organic psychosis. Severe hair loss related to PD treatment was reported in 43 cases (0.01%). The rates of hair loss under antipsychotic drugs were slightly lower than the mean rates of all PDs and antidepressant drugs. Valproic acid was related to the highest risk. In 6 of the 43 cases, hair loss was imputed to multiple drugs, with 4 cases imputed to double drug combinations and 2 cases to triple combinations. Rates of severe hair loss under valproic acid (VPA) and lithium salts were distinctly lower as compared with the overall rates reported in literature. Severe hair loss under PD treatment was reported significantly more often in female patients than in male patients (p < 0.01).Conclusion:The rate of severe PD-related hair loss was very low in the present survey. The large number of patients included in this multicentre study allows for assessment and comparison of hair loss rates related to different PDs and groups of PDs and provides new and supplementary information on PD-related hair loss.
39
Fierro, Carmen, Alessandro Medoro, Donatella Mignogna, Carola Porcile, Silvia Ciampi, Emanuele Foderà, Romeo Flocco, Claudio Russo, and Gennaro Martucci. "Severe Hypotension, Bradycardia and Asystole after Sugammadex Administration in an Elderly Patient." Medicina 57, no. 1 (January 19, 2021): 79. http://dx.doi.org/10.3390/medicina57010079.
Full textAbstract:
Background and Objectives: Sugammadex is a modified γ-cyclodextrin largely used to prevent postoperative residual neuromuscular blockade induced by neuromuscular aminosteroid blocking agents. Although Sugammadex is considered more efficacious and safer than other drugs, such as Neostigmine, significant and serious complications after its administration, such as hypersensitivity, anaphylaxis and, more recently, severe cardiac events, are reported. Case presentation: In this report, we describe the case of an 80-year-old male with no medical history of cardiovascular disease who was scheduled for percutaneous nephrolithotripsy under general anesthesia. The intraoperative course was uneventful; however, the patient developed a rapid and severe hypotension, asystole and cardiac arrest after Sugammadex administration. Spontaneous cardiac activity and hemodynamic stability was restored with pharmacological therapy and chest compression. The patient was stabilized and discharged uneventfully on postoperative day 10. Conclusions: The potential causes of cardiac arrest after Sugammadex administration have been carefully considered, yet all indications point to Sugammadex as the direct causative agent. On the basis of laboratory and clinical tests, we can exclude among the cause of bradycardia, Kounis syndrome, acute myocardial infarction, coronary spasm and other arrhythmias, but not anaphylaxis. Although Sugammadex is considered an increasingly important option in the prevention of postoperative residual neuromuscular blockade, anesthesiologists should consider it a causative agent of cardiac arrest during surgery. This case highlights the necessity of increased pharmacovigilance and further studies to examine Sugammadex safety and mechanism through which it may cause severe bradycardia, hypotension and cardiac arrest.
40
Dey, M., K. Bechman, C. Smith, A. Cope, E. Nikiphorou, and J. Galloway. "AB0649 INFECTION PROFILE OF IMMUNE-MODULATORY DRUGS USED IN AUTOIMMUNE DISEASES: ANALYSIS OF SUMMARY OF PRODUCT CHARACTERISTIC DATA." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1357.2–1358. http://dx.doi.org/10.1136/annrheumdis-2021-eular.2207.
Full textAbstract:
Background:The number of immune-modulatory drugs used to treat immune-mediated inflammatory diseases (IMIDs) has exponentially increased in recent decades. While effective in controlling disease, serious infection remains a concern.Accurate information on immune-modulatory drugs, including infections, is required to guide prescribing decisions. The “summary of product characteristics” (SmPC) by the European Medicines Agency (EMA) provides a useful repository of information on adverse events e.g. infections, from clinical trials and post-marketing pharmacovigilance (1).To date, no comparison has been undertaken on reported infection frequencies across SmPCs for immune-modulators.Objectives:To compare infection frequency, site and type across the most commonly-prescribed immune-modulatory drugs used to treat IMIDs, using information provided by SmPCs.Methods:A drug was included if licensed in Europe for treatment of one of the following: rheumatoid arthritis, axial spondyloarthritis, connective tissue disease, autoimmune vasculitis, autoinflammatory syndromes, inflammatory bowel disease (Crohn’s and ulcerative colitis), psoriasis, multiple sclerosis and other rarer conditions.The Electronic Medicines Compendium (EMC) was searched for commonly prescribed immune-modulatory drugs used for the above indications. SmPC documents were manually searched for information on infection frequency, extracted from sections 4.4 and 4.8. Infection frequency was recorded as per convention in the SmPC: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) (1), for each drug. Information was further extracted on infection site (e.g. respiratory, skin etc), type (e.g. bacterial, viral etc) and individual pathogenic organisms.25% of included SmPCs were screened and extracted by a second reviewer. Disagreements were resolved with input from a third reviewer.Results:In total, 39 drugs were included, used across 20 indications: nine conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), six targeted synthetic DMARDs (tsDMARDs; four Janus kinase [JAK] inhibitors, two sphingosine 1-phosphate receptor modulators) and 24 biologic DMARDs (17 cytokine-targeted; seven cell-targeted).Twelve sites of infection were recorded. Minimal or no site information was available for most csDMARDs and siponimod, certolizumab pegol and rituximab. The most common sites of infection are listed by drug group in Figure 1. Upper respiratory tract was the most common site, especially with bDMARDs. Lower respiratory, ear/nose/throat (including sinusitis) and urinary tract infections were moderately common, with clustering within drug groups. No drugs reported risk of cardiac infections; the eye, musculoskeletal, neurological, oral and reproductive sites were the least commonly-reported sites of infection.Infection data for 27 distinct pathogens were recorded, the majority viruses, especially with bDMARD use. Herpes simplex and zoster were the most frequently listed (mainly with bDMARDs and tsDMARDs), followed by influenza. Common non-viral causes of infection were candida and tinea species.Variable or absent reporting was noted for opportunistic infections (e.g. tuberculosis and fungi) and certain high-prevalence viruses e.g. Epstein-Barr.Conclusion:The SmPC literature reports differences in infection risk, by site and pathogen, between immune-modulatory drugs. The findings can be used to visualise differences and aid treatment decisions. However, some of the patterns we have shown lack face-validity to clinicians familiar with real-world safety data. The data fail to capture risk of rare infections, are likely skewed by trial selection criteria, varying number of trials per drug and quirks of individual study-reporting methodologies.The findings highlight the need for robust post-marketing pharmacovigilance studies.References:[1]A Guideline on Summary of Product Characteristics Module 1.3. 2008.Disclosure of Interests:None declared.
41
Finnes, Heidi D., Kari G. Chaffee, Timothy G. Call, Wei Ding, Deborah A. Bowen, Michael Conte, Kristen B. McCullough, et al. "The Importance of Pharmacovigilance during Ibrutinib Therapy for Chronic Lymphocytic Leukemia (CLL) in Routine Clinical Practice." Blood 126, no. 23 (December 3, 2015): 717. http://dx.doi.org/10.1182/blood.v126.23.717.717.
Full textAbstract:
Abstract Introduction: Ibrutinib has shown remarkable safety and efficacy in CLL. Due to CYP3A4 (3A4) metabolism, the concurrent use of 3A4 inhibitors/inducers with ibrutinib should be avoided. Ibrutinib is also associated with bleeding complications, in part due to effects on collagen-mediated platelet aggregation, thus caution is advised with the simultaneous use of anticoagulant (AC) and antiplatelet agents. It is unknown what proportion of CLL patients starting ibrutinib therapy in routine practice are on these medications. We conducted a retrospective study to evaluate these aspects in a large cohort of CLL pts treated with ibrutinib outside the context of clinical trials. Methods: Following IRB approval, consecutive CLL pts who initiated ibrutinib off-protocol at Mayo Clinic, Rochester, MN from November 2013 through July 2015 were evaluated. A medication review for drug-drug interactions was performed by a pharmacist on all pts. Baseline characteristics, concomitant medications, and toxicity were recorded. Time to toxicity and ibrutinib discontinuation were analyzed by Kaplan Meier and cumulative incidence methods accounting for competing risk of death, respectively. Results: Ninety-six CLL pts started ibrutinib. Median age was 66 years and 64 (67%) were male. Ibrutinib indications included: relapsed/refractory CLL (n=84), treatment-naïve CLL with del17p (n=8), and CLL with Richter's transformation (n=4). Approximately 80% had unmutated IGHV and 45% had del17p or del11q on FISH. Upon initial pharmacy consult prior to ibrutinib, the median number of concomitant medications was 9 (range, 1-31). Sixty (63%) pts were taking concurrent medications increasing their risk of ibrutinib toxicity and 4 (4%) pts were on drugs potentially reducing ibrutinib efficacy. At ibrutinib initiation, 16 (17%) pts were on concomitant 3A4 inhibitors. This included 9 (9%) on moderate 3A4 inhibitors (fluconazole, diltiazem, imatinib, cyclosporine) and 7 (7%) on strong 3A4 inhibitors (voriconazole, posaconazole, clarithromycin, itraconazole). In 4 pts, the 3A4 inhibitor was switched to another agent or discontinued to allow standard 420 mg daily dosing. Ibrutinib was initiated at 140 mg daily in 7 pts on moderate 3A4 inhibitors and at 140 mg every 48 hours in 5 pts on strong 3A4 inhibitors. Four (4%) pts were on strong 3A4 inducers (carbamazepine, rifampin, rifabutin) at the initiation of ibrutinib. The 3A4 inducer was discontinued prior to ibrutinib start in 3 pts, while the initial ibrutinib dose was decreased to 140 mg every 48 hours in the remaining patient (also on 2 strong 3A4 inhibitors). During the course of ibrutinib, an additional 8 (8%) pts were started on 3A4 inhibitors/inducers which necessitated dose modifications. Upon commencing ibrutinib, 9 (9%) pts were on concomitant AC (6 warfarin, 3 enoxaparin). Due to significant bleeding risk, warfarin was switched to enoxaparin in 2 pts, to aspirin (ASA) in 1 and warfarin was discontinued in 1. In 2 pts, an alternative AC could not be used so ibrutinib was begun at 140 mg daily and titrated upward. Twenty-nine (30%) pts were on ASA (3 [3%] also on clopidogrel) at ibrutinib initiation. Nineteen (20%) pts were on selective serotonin release inhibitors (SSRIs), and 9 (9%) were on NSAIDs. Thirteen (13%) pts were on fish oil and 24 (25%) were on herbal medications; all of which were discontinued prior to starting ibrutinib. Ten (10%) pts had clinically significant bleeding on ibrutinib including 4 (4%) requiring hospitalization (1 subdural hematoma). Of these 4 pts, 1 was on enoxaparin, 2 were on a SSRI and 1 a NSAID. Six pts had minor bleeding necessitating a dose reduction of ibrutinib to 140-280 mg daily. After 16 months follow-up, the risk of bleeding was 21% (95% CI: 1-37%, Figure). After a median follow-up of 7.6 months, 73 (76%) pts remain on ibrutinib. There was no difference in rates of discontinuation of ibrutinib between patients who were on 3A4 inhibitors/inducers versus those who were not. Conclusion: In the "real-world" setting, 2 out of 3 CLL patients commencing ibrutinib therapy is on a concomitant medication with a potentially clinically significant drug-drug interaction with ibrutinib. These findings have implications for the practicing hematologist who must maintain a high degree of vigilance when prescribing ibrutinib to CLL pts. We highly recommend a formal medication review by a clinical pharmacist in all patients initiating ibrutinib. Figure 1. Figure 1. Disclosures Ding: Merck: Research Funding. Kay:Hospira: Research Funding; Tolero Pharma: Research Funding; Genentech: Research Funding; Celgene Corporation: Membership on an entity's Board of Directors or advisory committees, Research Funding; Pharmacyclics: Research Funding; Gilead: Membership on an entity's Board of Directors or advisory committees, Research Funding. Shanafelt:Glaxo-Smith_Kline: Research Funding; Pharmactckucs: Research Funding; Celgene: Research Funding; Genentech: Research Funding; Cephalon: Research Funding; Janssen: Research Funding; Hospira: Research Funding; Polyphenon E Int'l: Research Funding.
42
Wang, Shuai, Anahat Kaur, Mariuxi Alexandra Viteri Malone, Tarek N. Elrafei, Lewis Steinberg, and Abhishek Kumar. "Cancer therapy related dysphonia: Analysis of real-world FAERS data." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): e18794-e18794. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.e18794.
Full textAbstract:
e18794 Background: Dysphonia is a rare and under-reported adverse event. It is associated with the use of several cancer drugs. Dysphonia has been included as possible side effect on packet insert (PI) for some medications, like regorafenib, lenvatinib and axitinib. However, dysphonia has not been reported on multiple other drugs. We aimed to conduct a more comprehensive study to generate signal for dysphonia as adverse effect of drugs used for oncologic indications. Methods: The United States Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database, a pharmacovigilance database, was used to extract data. All reported cases of dysphonia in the database were filtered for an indication of cancer. Descriptive analysis was conducted using SPSS 26. Results: Total 41840 cases of dysphonia were extracted from FAERS database. Out of these, cancer as an indication for medication use was noted in 2996 cases. Dysphonia was reported as side effect of 30 medications. Some of the most common medications were regorafenib (n=463), cabozantinib (290), lenvatinib (178), axitinib (176) and palbociclib (126) as noted in Table. Dysphonia was not listed as adverse reaction on PI for cabozantinib, palbociclib, sorafenib and oxaliplatin. However, it has been reported for regorafenib, lenvatinib and axitinib. Median age at diagnosis was 66 years (interquartile range 59-73). Dysphonia was reported more commonly in males (51.5%) as compared to females (46.2%). Reactions were reported to the FDA more commonly by consumers (53.3% cases) as compared to healthcare professionals (44.5% cases). Conclusions: This study demonstrates signal of developing dysphonia in patients receiving certain cancer directed medications based on FAERS database. It is worth noting that some of the suspect medications identified in this study do not have dysphonia listed as known adverse effect on accompanying package insert. Further studies need to be conducted to confirm if causal relationship exists between use of these drugs and development of dysphonia. Detailed description of five drugs used for oncologic indications with highest reported cases of dysphonia as adverse effect.[Table: see text]
43
Herrera Comoglio, Raquel. "I. Cloroquina / hidroxicloroquina y azitromicina. Revisión narrativa de seguridad." Latin american journal of clinical sciences and medical technology 2, no. 2 (May 15, 2020): 71–82. http://dx.doi.org/10.34141/ljcs2866115.
Full textAbstract:
The SARS-Co-2 pandemic is affecting millions of people, producing hundreds of thousands of deaths, and collapsing healthcare systems worldwide. Due to the lack of specific treatments, repurposed drugs are routinely used in in-hospital patients, though there is no sound-based scientific evidence. The quinine derivatives chloroquine (CQ) and hydroxychloroquine (HCQ) —used as antimalarials, and in autoimmune diseases—, and the antibiotic macrolide azithromycin have been proposed as possible therapies against the SARS-CoV-2 infection and COVID-19. Shortly after this outbreak began, many clinical trials have been registered to evaluate the efficacy of CQ/HCQ, alone or combined with azithromycin, in the treatment of COVID-19 or the prevention of SARS-CoV-2 infection. In the meantime, media information about the possible use of these drugs, politic leaders’ statements and further decisions concerning their efficacy soared public expectations. Both CQ/HCQ and azithromycin are relatively inexpensive and can be administered orally; adverse effects are known at doses used in approved indications. However, their use in a much more significant number of patients increases the risk of occurrence of adverse events. Notably, the potential of both drugs to prolong QTc interval raises concerns about the potentiality to lead to fatal arrhythmias, including torsades de pointes (TdP). The potential blood-glucose-lowering effect of CQ/HCQ could also produce serious adverse effects. The Spanish Pharmacovigilance system has received six cases of serious neuropsychiatric adverse reactions.This narrative review presents a summary of safety information of CQ/HCQ in approved indications, and the emerging experience of their use in the SARS-CoV-2 infection and COVID-19. With randomised clinical trials’ results not available yet, to May 20th 2020, the evidence of efficacy and effectiveness of CQ/HCQ do not suggest a benefit of this use as a treatment of COVID-19. For these purposes, CQ/HCQ alone or in combination with azithromycin should be used only in clinical trials.
44
Kaur, Anahat, Shuai Wang, Arlene Yu, Tarek N. Elrafei, Lewis Steinberg, and Abhishek Kumar. "Real-world risk of anosmia with cancer directed systemic therapy: A pharmacovigilance assessment using FDA Adverse Events Reporting System (FAERS) database." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): e18790-e18790. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.e18790.
Full textAbstract:
e18790 Background: Anosmia is a rare and under-reported adverse event associated with the use of several oncologic drugs. Instances of olfactory disturbances following administration of chemotherapeutic agents have been sporadically documented in case reports and case series. We aimed to conduct a more comprehensive study to generate signal for anosmia as adverse effect of drugs used for oncologic indications. Methods: The United States Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database, a pharmacovigilance database, was used to extract data. All reported cases of anosmia in the database were filtered for an indication of cancer. Descriptive analysis was conducted using SPSS 26. Results: Total 10250 cases of anosmia were extracted from FAERS database. Out of these, cancer as an indication for medication use was noted in 139 cases. Some of the most common suspect medications exclusively associated with more than one case of anosmia were palbociclib (n=16), enzalutamide (13), pazopanib (8), cabozantinib (8), letrozole (6), leuprolide (5), niraparib (5), rucaparib (4), tamoxifen (4), capecitabine (3), everolimus (3), anastrazole (2), exemestane (2), zoledronic acid (2), vandetanib (2) and vismodegib (2). Detailed description of medications with highest number of reported cases is listed in Table. Median age at diagnosis was 66 years (interquartile range 58-71). Anosmia was reported more commonly in females (64% ) as compared to males (33.8%). Reactions were reported to the FDA more commonly by consumers (56.8%) as compared to healthcare professionals (40.3% cases). Out of 139 patients with anosmia, 93 (66.9%) had concomitant ageusia, 8 (5.7 %) had dysgeusia and 6 (4.3%) patients had neuropathy. Conclusions: This study demonstrates a signal for anosmia as side effect in patients receiving select oncologic medications based on the FAERS database. It is worth noting that none of the suspect medications identified in this study have anosmia listed as known adverse reaction on accompanying package insert. Further studies need to be conducted to confirm if causal relationship exists between use of these drugs and olfactory function compromise. [Table: see text]
45
Mantzaris, Gerassimos J. "Anti-TNFs: Originators and Biosimilars." Digestive Diseases 34, no. 1-2 (2016): 132–39. http://dx.doi.org/10.1159/000443128.
Full textAbstract:
In the last 20 years, the advent of anti-tumor necrosis factor alpha (TNFα) biologics has revolutionized the treatment of patients with inflammatory bowel disease (IBD) but the cost of biologic therapy now constitutes a large proportion of all healthcare expenditures. Patent expiration has sparked the healthcare industry's interest in the production of biosimilar (BS) versions of first generation biologics (originators [ORGs]) for market sharing. Having no access to the production line of the ORG, the sponsor of a BS needs to develop his own manufacturing process to produce a highly similar version of the reference product. Similarity in structure, physicochemical properties, biologic activity, efficacy and safety must be demonstrated by a comprehensive comparability exercise that includes the most sensitive in vitro tests, models and clinical condition with pre-defined equivalence margins. Extrapolation of indications, inter-changeability and automatic substitution between BS and ORG depend on a legal framework that varies between different agencies. It is not, therefore, unexpected that marketing authorization by the European Medicines Agency and other regulatory agencies (but not Health Canada) of CT-P13 (Remsima™/Inflectra™) as infliximab (Remicade®) BSs for IBD by indication extrapolation has led to stormy discussions in the IBD community and beyond regarding the scientific adequacy of this decision. However, as we now have to live with BSs, we hope that the impeding automatic substitution in association with post-marketing pharmacovigilance, full traceability, registries and new studies will settle the controversy and will increase the confidence of physicians and patients. A universally adopted legal framework should be implemented because, as expected, the non-anti-TNFα BSs will be soon on the stage.
46
Sardella, Marco, and Calin Lungu. "Evaluation of quantitative signal detection in EudraVigilance for orphan drugs: possible risk of false negatives." Therapeutic Advances in Drug Safety 10 (January 2019): 204209861988281. http://dx.doi.org/10.1177/2042098619882819.
Full textAbstract:
Different strategies have been studied to allow a better characterization of the safety profile of orphan drugs soon after their approval. At the end of the development phases only few data are available because of the small number of subjects exposed to an orphan medicine for the treatment of rare or ultra-rare conditions. As a consequence, the evaluation of the safety profile is limited at the time of the first approval. In the post-marketing period, all available sources should be combined for a better understanding of the safety of orphan drugs. These sources, include outputs from large databases such as the European Medicines Agency’s EudraVigilance database. Analyses of data from this source are required to be performed by marketing authorization holders (MAHs) as part of their signal management activities. In 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) assessed 114 confirmed signals, 79% of which included data from EudraVigilance. MAHs have access to statistical calculations for drug–event combinations (DECs) from EudraVigilance, provided in the form of measures of disproportionality of ratios of the observed proportion of spontaneous cases for a DEC in relation to the proportion of cases that would be expected if no association existed between the drug and the event. However, such statistical summaries for orphan drugs could be misleading because of the very limited safety data available for orphan drugs (under-reporting together with low numbers of exposed patients). In addition, the applied statistical methodology in most instances is constrained by different confounding factors such as indications of specific medicines and the wide spectrum of medical conditions/diseases of patients from whom reporting of disproportionality ratios are derived (i.e. proportions of DECs for orphan drugs (ODECs) from a small patient population suffering the rare disease and the proportion of DECs in the rest of the population represented in the whole database who have been treated with other medicines for a wide range of indications, and prescribed to treat completely different medical conditions). As expected, these statistical calculations produced not only signals of disproportionate reporting (SDRs) that are false positives, but also not sensitive enough to detect certain SDRs, thus resulting in false negatives. In the context of rare/ultra-rare life-threatening diseases where new molecules have been made available on the market on the basis of their proven efficacy, but with only limited safety data at the time of approval, false negatives could be a special concern since unlikely converted in positives or becoming positives with notable delay. Subgroup analyses (using a limited dataset comprising ADRs within specific individual case safety reports (ICSRs), sorted by indication/disease relevant to the drug of interest could, at least in part, possibly reduce some of the weaknesses resulting from the abovementioned confounding factors. On the other hand it could also cause the loss of some identification of SDRs that would be captured if no database restrictions had been undertaken. Therefore, data subgroup analysis should not be selected as a preferred approach to quantitative signal detection for orphan drugs but rather evaluated as complementary possibly to confirm negatives or to further characterize detected SDRs. Some examples of false negatives originating from quantitative signal detection in EudraVigilance applied to orphan drugs are discussed in this article.
47
Cosentino, Lidia, Paula D. James, Michelle Sholzberg, and Alfonso Iorio. "Interim Canadian Data from a Prospective, Observational Study of Routine Clinical Use of a Von Willebrand Factor Concentrate (Wilate®)." Blood 128, no. 22 (December 2, 2016): 2593. http://dx.doi.org/10.1182/blood.v128.22.2593.2593.
Full textAbstract:
Introduction:Von Willebrand disease (VWD) is the most common congenital bleeding disorder with a prevalence of symptomatic cases of 1 in 1,000. VWD is characterized by quantitative or qualitative abnormalities in von Willebrand factor (VWF), resulting in impaired haemostasis. To increase VWF levels, VWF concentrates are the only treatment option for approximately 20% of VWD patients for whom 1-deamino-8-D-arginine vasopressin (DDAVP) is not effective or is contraindicated. Wilate® (Octapharma AG, Lachen, Switzerland) is a high purity, double virus-inactivated, freeze-dried concentrate of VWF and FVIII. The ratio of VWF to FVIII is near the physiological value of 1:1 and is designed to simplify dosing and monitoring. Wilate®, initially approved in 2005 in Germany, is currently broadly approved worldwide for treatment of VWD and Hemophilia A. This non-interventional, prospective study in VWD patients was designed to collect information on the safety, tolerability and efficacy of Wilate® in routine clinical practice. We present the results of an interim analysis conducted in Canadian patients who received Wilate® in a routine clinical setting as prophylaxis, on-demand treatment and/or in a surgical setting. Methods:Ethics committee approval was obtained from all participating centres, and all VWD patients prescribed Wilate® from participating physicians were eligible for inclusion. Patients were excluded for the presence of VWF inhibitors, bleeding disorders other than VWD, a history of non-compliance, prohibitively difficult venous access, or the inability to follow study requirements. Routine clinical use of Wilate® for prophylaxis, on demand treatment of bleeding episodes, and prophylaxis for major and minor surgeries were documented. Parameters of routine clinical use are reported here and include exposure days, dosing, and number of infusions. Adverse drug reactions (ADRs), tolerability assessments, and haemostatic efficacy assessments are also reported. Results:Interim data from 13 patients, with a mean age of 45.6 (range 16 to 78 years), enrolled in participating Canadian centres was available for this analysis. Patients consisted of 3 males and 10 females, nine with type 1, three with type 2, and one with type 3 VWD. Two patients were treated for on-demand bleeding episodes, 2 were treated prophylactically, whereas 11 patients were treated for surgeries. A total of 1 051 000 IU Wilate® was infused in the thirteen patients with an average dose for all indications of 46 ± 9.7 IU/kg. Tolerability was 'excellent' in 284 of 285 (99.6%) assessed infusions. Hemostatic efficacy of Wilate® was assessed as 'excellent' or 'good' for all on-demand treatments of bleeding episodes. All 29 breakthrough bleeds, which were primarily GI bleeding, were treated successfully in one long-term prophylactic patient with severe VWD in 17 months. One other patient was treated for seventeen days following surgery and experienced no bleeding episodes. Eleven patients underwent 12 surgical procedures, one patient underwent 2 minor dental procedures, and 10 patients underwent ten major surgeries. In all 12 surgeries the haemostatic efficacy of Wilate® treatment was assessed as 'excellent.' No thrombotic events or severe ADRs were observed. Conclusion:This study is a part of ongoing pharmacovigilance of Wilate® and these interim observations support its safety and efficacy for VWD patients in routine clinical settings. In our Canadian cohort, under routine clinical conditions, bleed resolution, prevention, and tolerability were high. Disclosures Cosentino: Octapharma: Employment. James:CSL Behring: Research Funding; Octapharma: Research Funding; Biogen: Consultancy; Basalt: Consultancy; Bayer: Research Funding. Sholzberg:Shire (previously Baxter, Baxalta): Honoraria, Research Funding; Novonordisk: Honoraria.
48
Zozulya, N. I., O. I. Yastrubinetskaya, S. S. Belyaeva, V. M. Potapkova, I. L. Davydkin, I. V. Kurtov, T. V. Shelekhova, et al. "The results of the use of Octofactor in patients with moderate and severe hemophilia A (data from a prospective, multicenter, open-label, observational study)." Russian Journal of Pediatric Hematology and Oncology 6, no. 2 (April 24, 2019): 30–47. http://dx.doi.org/10.21682/2311-1267-2019-6-2-30-47.
Full textAbstract:
Relevance. In accordance with the guidelines on the clinical investigation of clotting factor VIII products of the European Medicines Agency and guidelines on pharmacovigilance of the Eurasian Economic Union, after registration of a new drug, it is recommended to study its efficacy and safety on a large population of patients in a standard medical practice to clarify and identify new data.Materials and methods. In a prospective, multicenter, open-label, uncontrolled observational study, the efficacy and safety of the domestic recombinant B-domain deleted blood clotting factor FVIII (FVIII) (moroctocog alfa, Octofactor®, JSC “GENERIUM”) in patients with moderate and severe hemophilia A in the context of standard medical practice (study protocol number CI-51/15). Patients received the drug in terms of standard medical practice for the purpose of prophylactic treatment or on demand treatment. For prophylactic treatment Octofactor was administered to patients according to the instructions for medical use in a single dose of 20–40 IU/kg every 2–3 days. In the case of bleeding a single dose of Octofactor was calculated taking into account the severity and localization of bleeding in accordance with the instructions for medical use. The results of the treatment were analyzed for a period of 52 ± 2 weeks. The main parameter for evaluating the efficacy was the frequency of spontaneous bleeding that occurred within 48–72 hours after the administration of the Octofactor. Additional parameters for evaluating the efficacy included: the severity of spontaneous bleeding arising during the prophylactic treatment; the number of injections and the total dose of the Octofactor to stop 1 episode of bleeding; the amount of Octofactor used during the entire observation period (52 ± 2 weeks) and for 1 month both for prophylaxis and for stopping the bleeding that occurred; an indicator of the efficacy of therapy on the scale for determining the response to treatment of acute hemarthrosis (World Federation of Hemophilia, WFH).Results.According to the results of the screening survey 237 male patients aged from 19 to 78 years old (mean age 35.2 ± 11.1 years) with moderate and severe hemophilia A (FAS-population) were included in the study. The efficacy of therapy was evaluated in 202 patients who underwent all the planned procedures during the observation period (PP-population). 193 (95.5 %) patients received prophylactic treatment, 9 (4.5 %) patients received on-demand treatment. Evaluation of the efficacy of treatment was carried out on the basis of basic and additional parameters. The main parameter for evaluating the efficacy – the frequency of spontaneous bleeding that occurred within 48–72 hours after the administration of the Octofactor – was 52 ± 2 weeks within 1.4 ± 2.9 cases. At the same time, the proportion of spontaneous bleeding that occurred within 48–72 hours after administration of the Octofactor preparation was 45.2 % of the total number of spontaneous bleeding and 15.6 % of the total number of all bleeding in patients who received prophylactic treatment. Among 608 spontaneous bleeding that occurred in patients receiving prophylactic treatment, 287 (47.2 %) of the bleeding were mild, 289 (47.5 %) were moderate and 32 (5.3 %) were heavy. Of the 275 spontaneous bleeding that occurred within 48–72 hours after administration of the study drug for prophylactic purposes, 117 (42.5 %) episodes were mild, 146 (53.1 %) were moderate, and 12 (4.4 %) were severe. With prophylactic administration the average single dose of the Octofactor was 2036.3 ± 884.7 IU, or 27.3 ± 11.2 IU/kg, in the treatment of bleeding occured during prophylactic treatment – 2227.7 ± 1087 IU, in the treatment of bleeding in patients receiving the drug only on demand – 2280.7 ± 1037.2 IU. The average monthly intake of the drug by one patient in prophylactic treatment was 19.75 ± 9.75 thousand IU, while the average monthly consumption of the drug for preventing bleeding from one patient was 17.16 ± 9.13 thousand IU for stopping bleeding against the background prevention – 3.87 ± 3.97 thousand IU. One patient who received on-demand treatment had an average monthly average of 13.47 ± 13.46 thousand IU of the Octofactor preparation. For stopping 1 bleeding, on average, 1.7 ± 1.7 injections of the Octofactor preparation were required, in the prophylactic treatment group – 1.8 ± 1.8, and in the on-demand treatment group – 1.5 ± 1.1. In the overwhelming majority of cases, patients of both groups showed excellent and good response to all treatment of acute hemarthrosis on the scale of the WFH on all visits, the reaction was moderate in a few episodes, and only in 1 case of acute hemarthrosis there was no response to the drug administration. The safety of therapy was evaluated in 228 patients who received at least 1 Octofactor administration during the study (mITT-population). There were 66 adverse events in 40 patients, 10 of them were associated with the use of the drug, the most significant of which were the formation of inhibiting antibodies to FVIII in low titer (1.5 U) in 1 patient and the development of allergic reactions in 2 patients.Conclusions.Under the conditions of standard medical practice the efficacy and safety of Octofactor was confirmed for both prophylactic treatment and on-demand bleeding treatment in adult patients with severe and moderate hemophilia A.
49
Khalili, Malahat, Hamid Sharifi, Bita Mesgarpour, Mehrnaz Kheirandish, Sten Olsson, Naghmeh Javidnikou, and Ali Akbar Haghdoost. "Evaluation of Pharmacovigilance System in Iran." International Journal of Health Policy and Management, December 14, 2020. http://dx.doi.org/10.34172/ijhpm.2020.243.
Full textAbstract:
Background: Evaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug reaction (ADR) reports and other opportunities for pharmacovigilance systems strengthening. This study aimed to evaluate the status of pharmacovigilance in Iran using the World Health Organization (WHO) pharmacovigilance indicators with the prospect of identifying the gaps and areas for improvement. Methods: This study was conducted in 2 parts. The first part included a secondary analysis of the national data obtained from the Iranian National Pharmacovigilance Center (PVC) using a structured data collection form based on WHO core pharmacovigilance indicators. In the second part, a 3-month prospective study was carried out to investigate 2 outcome indicators, ie, length of stay and costs of medicine-related hospitalization in all patients of 2 main referral hospitals in the southeast and north of Iran. Results: Iran has a PVC with national policy, trained staff, and a statutory budget. In 2017, the number of ADR reports was 15.0 per 100 000 population, and 262 signals were detected during the preceding 5 years. The average length of stay and costs of medicine-related hospitalization were 5 days and US$817.2 in Afzalipour hospital and 6.6 days and US$306.7 in Razi hospital, respectively. The status of pharmacovigilance in the Iranian public health programs (PHPs) is unknown, and most of the indicators could not be assessed. Conclusion: A robust pharmacovigilance system is a pivotal part of the overall medicines regulatory system. The Iranian pharmacovigilance system has relatively the proper structural condition. Though the underreporting of ADRs, especially medicine-related deaths, is an important issue, and some indicators’ status was unclear. The Iranian pharmacovigilance program requires a higher prioritization, particularly in the PHPs, a greater allocation of resources, and cross-sectoral cooperation to bolster and achieve the pharmacovigilance objectives.
50
Opadeyi, Abimbola O., Annie Fourrier-Réglat, and Ambrose O. Isah. "Assessment of the state of pharmacovigilance in the South-South zone of Nigeria using WHO pharmacovigilance indicators." BMC Pharmacology and Toxicology 19, no. 1 (May 31, 2018). http://dx.doi.org/10.1186/s40360-018-0217-2.
Full text