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Raj, Nikhil, Swapnil Fernandes, Narayana R. Charyulu, Akhilesh Dubey, Ravi G. S., and Srinivas Hebbar. "Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada." Therapeutic Advances in Drug Safety 10 (January 2019): 204209861986541. http://dx.doi.org/10.1177/2042098619865413.
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Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product. However, such prescriptions are carried out in a controlled manner. Prior to being approved, the medicinal product will have been evaluated in a population pool containing fewer than 5,000 patients and in a predesigned environment where several factors may be lacking, such as the absence of women of childbearing potential, geriatric patients and paediatric patients. Therefore, it is not surprising that several major adverse drug reactions are detected only when the product has been prescribed to the general population. National and international regulatory bodies have devised systems for monitoring medicinal products after marketing, commonly known as postmarketing surveillance systems. Postmarketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the successful completion of clinical trials. The primary purpose for conducting postmarketing surveillance is to identify previously unrecognized adverse effects as well as positive effects. The Yellow Card scheme, practiced in the United Kingdom and the Canada Vigilance Program adopted in the Canadian jurisdiction, are two of the most successful postmarketing surveillance systems implemented across the world. Therefore, this article intends to discuss postmarketing surveillance and its role in the context of the United Kingdom and Canadian jurisdictions with a view on presenting key aspects and measures that are employed for operating an efficient postmarketing surveillance system in regulated markets.
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Gozzo, Lucia, Antonella Nardo, Serena Brancati, Antongiulio Judica, Andrea Duminuco, Cinzia Maugeri, Marina Parisi, et al. "Severe Gastrointestinal Toxicity Following the Use of Gilteritinib: A Case Series and Analysis of Postmarketing Surveillance Data." Healthcare 11, no. 10 (May 18, 2023): 1479. http://dx.doi.org/10.3390/healthcare11101479.
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Gilteritinib has been approved as monotherapy in adults with acute myeloid leukemia (AML) FLT3 mutated with relapsed or refractory disease, in light of its advantages in terms of survival and the favorable safety profile. Hepatobiliary disorders and musculoskeletal and connective tissue disorders represent the most frequent adverse reactions associated with gilteritinib, whereas the most frequent serious adverse reaction is acute kidney injury. In the summary of product characteristics, gastrointestinal (GI) events are indicated as very common, in particular diarrhea, nausea and stypsis. Furthermore, serious GI disorders have been observed with gilteritinib in clinical trials, including GI hemorrhage, GI perforation and GI obstruction. However, the association with the FLT3 inhibitor has not been confirmed. Nevertheless, serious GI AEs have been recognized as an important potential risk to be monitored in postmarketing surveillance. We present three cases of serious self-limiting GI events observed in patients on gilteritinib treatment for AML, and an analysis of relevant available postmarketing surveillance data.
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Fahmy, Sahar, and Eman Abu-Gharbieh. "In VitroDissolution andIn VivoBioavailability of Six Brands of Ciprofloxacin Tablets Administered in Rabbits and Their Pharmacokinetic Modeling." BioMed Research International 2014 (2014): 1–8. http://dx.doi.org/10.1155/2014/590848.
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This study was undertaken to assess thein vitrodissolution andin vivobioavailability of six brands of ciprofloxacin oral tablets available in the UAE market using rabbits. Thein vitrodissolution profiles of the six ciprofloxacin products were determined using the USP dissolution paddle method. Pharmacokinetic modeling using compartmental and noncompartmental analysis was done to determine the pharmacokinetic parameters of ciprofloxacin after single-dose oral administration.In vitrorelease study revealed that the amount of ciprofloxacin released in 20 minutes was not less than 80% of the labeled amount which is in accordance with the pharmacopoeial requirements. All tested products are considered to be very rapid dissolving except for formulae A and D. Ciprofloxacin plasma concentration in rabbits was best fitted to a two-compartment open model. The lowest bioavailability was determined to be for product A (93.24%) while the highest bioavailability was determined to be for product E (108.01%). Postmarketing surveillance is very crucial to ensure product quality and eliminating substandard products to be distributed and, consequently, ensure better patient clinical outcome. The tested ciprofloxacin generic products distributed in the UAE market were proven to be of good quality and could be used interchangeably with the branded ciprofloxacin product.
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Guharoy, Roy, Gregory Cwikla, Andrew Burgdorf, and Madan Joshi. "Prescription for a Stronger FDA." Journal of Pharmacy Practice 19, no. 5 (October 2006): 295–96. http://dx.doi.org/10.1177/0897190007299704.
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Recently, an Institute of Medicine panel concluded that years of negligence, mismanagement, inadequate resources, infighting among staff members, and lack of a systemic drug approval and postmarketing surveillance process have diluted the effectiveness of the Food and Drug Administration (FDA) in protecting public health. The panel was commissioned by the FDA to assess the U.S. drug safety system, and they recommended 25 sweeping changes, most of which would require congressional authorization. The recommendations focus on the life cycle of a drug product, rather than just the approval process, and they would go a long way in protecting public health in the future.
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Dunlop, Joan H. "Oral immunotherapy for treatment of peanut allergy." Journal of Investigative Medicine 68, no. 6 (July 14, 2020): 1152–55. http://dx.doi.org/10.1136/jim-2020-001422.
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The US Food and Drug Administration’s approval of a peanut oral immunotherapy product in January 2020 is a landmark development in the field of food allergy therapy. While food allergy prevalence has been increasing, this product is the first approved therapy for food allergy. Oral immunotherapy has many similarities to subcutaneous immunotherapy and drug desensitization protocols, but does not lead to sustained unresponsiveness. The studies leading to approval of the Palforzia product demonstrated increase in the amount of peanut protein able to be consumed, with 67% of subjects randomized to the treatment arm able to consume 600 mg of peanut protein in double-blind placebo-controlled food challenge at study exit. However, side effects are an important consideration, and dropout rates in studies of Palforzia ranged from 11% to 21%. Postmarketing surveillance of this product will be critical in assessing its long-term risks and benefits.
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Banach, Maciej, Niki Katsiki, Gustavs Latkovskis, Manfredi Rizzo, Daniel Pella, Peter Penson, Željko Reiner, and Arrigo Cicero. "Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia." Archives of Medical Science 17, no. 4 (July 16, 2021): 856–63. http://dx.doi.org/10.5114/aoms/133716.
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IntroductionIn the absence of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions to secure a high level of product safety. This paper describes the use of a nutrivigilance system in monitoring the incidence of spontaneously reported suspected adverse reactions associated with food supplements containing red yeast rice (RYR).Material and methodsWe report the data from a widely used product marketed under the trademark Armolipid/Armolipid Plus. Postmarketing information was collected in a voluntary nutrivigilance system established by the manufacturing company (Meda Pharma SpA, a Viatris Company, Monza, Italy). From 1st October 2004 to 31st December 2019, this system captured cases of suspected adverse reactions spontaneously reported by consumers, healthcare professionals, health authorities, regardless of causality.ResultsThe total number of case reports received mentioning the RYR food supplement product line was 542, in which 855 adverse events (AEs) were reported. The total reporting rate of AEs was estimated to be 0.037% of 2,287,449 exposed consumers. Of the 542 cases, 21 (0.0009% of exposed consumers) included suspected serious adverse events (SAEs). After careful investigation, 6 cases (0.0003% of consumers exposed) and 6 AEs were assessed by the manufacturer as serious and potentially related to exposure to the above-mentioned RYR-based nutraceutical.ConclusionsThis nutrivigilance-derived data analysis clearly demonstrates a low prevalence of suspected adverse events associated with the red yeast rice product line. Consumer safety of food supplements could be generally improved by raising awareness of the importance of following the indications and warnings detailed in a food supplement’s labeling.
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Ciccone, Valerio, Marina Ziche, Andrea Spini, and Sandra Donnini. "Uncovering Knowledge Gaps in the Safety Profile of Antiangiogenic Drugs in Cancer Patients: Insights from Spontaneous Reporting Systems Studies." Pharmaceuticals 16, no. 6 (June 12, 2023): 867. http://dx.doi.org/10.3390/ph16060867.
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Global repositories of postmarketing safety reports improve understanding of real-life drug toxicities, often not observed in clinical trials. The aim of this scoping review was to map the evidence from spontaneous reporting systems studies (SRSs) of antiangiogenic drugs (AADs) in cancer patients and highlight if the found disproportionality signals of adverse events (AEs) were validated and thus mentioned in the respective Summary of product Characteristics (SmPC). This scoping review was conducted according to PRISMA guidelines for scoping reviews. A knowledge gap on the safety of AADs was found: firstly, several cardiovascular AEs were not mentioned in the SmPCs and no pharmacovigilance studies were conducted despite the well-known safety concerns about these drugs on the cardiovascular system. Second, a disproportionality signal (not validated through causality assessment) of pericardial disease was found in the literature for axitinib with no mention in SmPC of the drug. Despite the exclusion of pharmacoepidemiological studies, we believe that this scoping review, which focuses on an entire class of drugs, could be considered as a novel approach to highlight possible safety concerns of drugs and as a guide for the conduction of a target postmarketing surveillance on AADs.
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Harvey, R. Donald. "Science of Biosimilars." Journal of Oncology Practice 13, no. 9_suppl (September 2017): 17s—23s. http://dx.doi.org/10.1200/jop.2017.026062.
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Biosimilar therapeutic proteins in oncology offer the potential to decrease costs while providing safety and efficacy profiles consistent with their respective reference or originator products. Biosimilars have a number of important differences from generic small-molecule drugs, including manufacturing processes that are unique from their reference products. These differences may affect biosimilars through posttranslational modifications that can occur in specific cellular production lines, and these modifications have potential effects on protein structure, function, clinical pharmacology, and immunogenicity. Regulatory agencies expect these differences to be identified, analyzed, and minimized through iterative processes and extensive preclinical efforts. Generic naming of biosimilars reflects the nonproprietary reference product name along with a meaningless four-letter suffix to ensure that each product can be uniquely identified for prescribing and pharmacovigilance purposes. Labeling information for biosimilars reflects a greater detail of comparisons to reference products than conventional generic drugs, which ensures that prescribers can understand the source of information and have a complete understanding of the therapeutic profile of each biosimilar agent. Postmarketing surveillance programs will be required to evolve and ensure optimal pharmacovigilance reporting, because the potential for unexpected adverse events with biosimilars is higher than with conventional generic agents as a result of different manufacturing processes and different clinical trial designs and durations. The existing filgrastim biosimilars are likely to be joined soon by therapeutic monoclonal antibodies, including rituximab, trastuzumab, and bevacizumab, on the basis of patent expiration dates and clinical trial results.
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Sader, Helio S., Paul R. Rhomberg, Andrew S. Fuhrmeister, Rodrigo E. Mendes, Robert K. Flamm, and Ronald N. Jones. "Antimicrobial Resistance Surveillance and New Drug Development." Open Forum Infectious Diseases 6, Supplement_1 (March 2019): S5—S13. http://dx.doi.org/10.1093/ofid/ofy345.
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Abstract Surveillance represents an important informational tool for planning actions to monitor emerging antimicrobial resistance. Antimicrobial resistance surveillance (ARS) programs may have many different designs and can be grouped in 2 major categories based on their main objectives: (1) public health ARS programs and (2) industry-sponsored/product-oriented ARS programs. In general, public health ARS programs predominantly focus on health care and infection control, whereas industry ARS programs focus on an investigational or recently approved molecule(s). We reviewed the main characteristics of industry ARS programs and how these programs contribute to new drug development. Industry ARS programs are generally performed to comply with requirements from regulatory agencies responsible for commercial approval of antimicrobial agents, such as the US Food and Drug Administration, European Medicines Agency, and others. In contrast to public health ARS programs, which typically collect health care and diverse clinical data, industry ARS programs frequently collect the pathogens and perform the testing in a central laboratory setting. Global ARS programs with centralized testing play an important role in new antibacterial and antifungal drug development by providing information on the emergence and dissemination of resistant organisms, clones, and resistance determinants. Organisms collected by large ARS programs are extremely valuable to evaluate the potential of new agents and to calibrate susceptibility tests once a drug is approved for clinical use. These programs also can provide early evaluations of spectrum of activity and postmarketing trends required by regulatory agencies, and the programs may help drug companies to select appropriate dosing regimens and the appropriate geographic regions in which to perform clinical trials. Furthermore, these surveillance programs provide useful information on the potency and spectrum of new antimicrobial agents against indications and organisms in which clinicians have little or no experience. In summary, large ARS programs, such as the SENTRY Antimicrobial Surveillance Program, contribute key data for new drug development.
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Iorio, Alfonso, Paolo Puccetti, and Mike Makris. "Clotting factor concentrate switching and inhibitor development in hemophilia A." Blood 120, no. 4 (July 26, 2012): 720–27. http://dx.doi.org/10.1182/blood-2012-03-378927.
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The development of alloantibodies or inhibitors is the most serious complication a patient with severe hemophilia can experience from treatment with clotting factor concentrates. Although common in previously untreated patients, inhibitor development is rare in multiply exposed, well-tolerized patients. There has been a nonevidence-based reluctance to change concentrate because of a perceived greater inhibitor risk after the switch, even though most patients are now likely to be using a concentrate on which they did not begin. Inhibitors in previously treated patients are observed in approximately 2 per 1000 patient/years, which makes it difficult to study and compare rates among different products. Because the baseline inhibitor risk in previously treated patients may vary over time, it is important to compare the risk in patients switching to a new product with that in a parallel control group of nonswitching patients or within a case-controlled study. The study designs imposed by regulators are suboptimal in detecting immunogenicity signals. The issue of immunogenicity of new products is likely to gain more relevance in the near future, with a call for effective postmarketing surveillance studies for all of the new engineered factor VIII concentrates with prolonged half-lives that are likely to enter clinical practice.
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Tallman, Martin S., Francesco Lo-Coco, and Ashutosh Pathak. "Long-Term Safety Experience with Arsenic Trioxide in Patients with Acute Promyelocytic Leukemia." Blood 128, no. 22 (December 2, 2016): 4034. http://dx.doi.org/10.1182/blood.v128.22.4034.4034.
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Abstract Introduction: Therapeutic agents approved by the FDA are required to undergo postmarketing safety surveillance to meet regulatory and contractual requirements. Arsenic trioxide (Trisenox®) is approved for the treatment of patients with acute promyelocytic leukemia (APL) in the second-line setting, but is also commonly used in first-line regimens in combination with all-trans retinoic acid. Here, we summarize the accumulated safety data from global postmarketing surveillance of arsenic trioxide since its initial approval in 2000 to better understand its long-term safety in patients with APL. Methods: Cumulative data were collected from patients with APL since initial approval in 2000 from spontaneous reports submitted by healthcare professionals and consumers. The data collected were housed in the Teva Pharmaceuticals safety database. Adverse events (AEs) were coded according to MedDRA terms and classified by seriousness and expectedness (unexpected AEs are those not included in the product label at the time of the report or those that occurred at a higher incidence than previously reported). Results: As of July 7, 2016, a total of 2197 AE reports were received in association with arsenic trioxide use in patients with APL. There were 1735 reports classified as serious and 462 classified as nonserious. The most frequently reported (≥ 30 reports) serious AEs and serious AEs of interest are summarized in the table. Serious QT prolongation was the most commonly reported event, but the majority of events were expected, including four cases of torsades de pointes that may be associated with prolonged QT. Serious hematologic toxicities, including neutropenia and leukocytosis, were also common and expected, as was liver toxicity. The most common serious and unexpected events reported included white blood cell decrease, pancytopenia, increased gamma-glutamyltransferase level, and cardiac disorders (primarily ventricular tachycardia, ventricular extrasystoles) that may be associated with prolonged QT in some patients. Conclusions: The overall safety profile of arsenic trioxide is consistent with known toxicities; the majority of serious AEs are associated with QT prolongation. The clinical significance of the reported QT events is unclear, and reporting rates may change in the future because of evolving criteria for QT assessments (Roboz GJ, et al. J Clin Oncol 2014;32(33):3723). This overview was limited by voluntary reporting. However, the long-term, real-world experience with arsenic trioxide administration as a single agent or in combination provides a broader understanding of its safety profile. Sponsor: Teva Branded Pharmaceutical Products R&D Disclosures Lo-Coco: Teva, Novartis, Baxalta, Pfizer: Consultancy; Teva, Lundbeck: Honoraria, Speakers Bureau. Pathak:Teva Pharmaceuticals: Employment, Equity Ownership.
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Haider, Mahnur, Syed Ahsan Rizvi, and Pashtoon Murtaza Kasi. "Nelarabine Associated Myotoxicity and Rhabdomyolysis." Case Reports in Hematology 2015 (2015): 1–4. http://dx.doi.org/10.1155/2015/825670.
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Nelarabine (ara-G; Arranon; compound 506U78) is an antineoplastic purine analog used for the treatment of refractory or relapsed T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). The drug was granted accelerated approval in October 2005 by the US Food and Drug Administration (FDA) given the efficacy (induction of complete responses) noted in 2 single-arm trials (one in pediatric setting and one in adult patient population). The main spectra of toxicities that have been reported in these clinical trials and subsequent studies are hematological and neurological. Nelarabine induced rhabdomyolysis and increased creatinine phosphokinase (CK; CPK) levels apparently have been reported and this side effect has been added as an adverse reaction in the product monograph from the drug company during postmarketing surveillance. However, the true extent and incidence of the myotoxicity from the drug are unclear. In this paper we report a grade IV CK elevation and rhabdomyolysis in a patient with T-ALL treated with nelarabine. Given the reported finding, we examined the literature further for myotoxicity, increased CK, and/or rhabdomyolysis associated with the use of the nelarabine and report our findings.
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Pfäffle, Roland, Karl Otfried Schwab, Otilia Marginean, Mieczyslaw Walczak, Mieczyslaw Szalecki, Ellen Schuck, Markus Zabransky, and Stefano Zucchini. "Design of, and first data from, PATRO Children, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope® in children requiring growth hormone treatment." Therapeutic Advances in Endocrinology and Metabolism 4, no. 1 (February 2013): 3–11. http://dx.doi.org/10.1177/2042018813479644.
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Objective: To describe the rationale, design and first data from PATRO Children, a postmarketing surveillance of the long-term efficacy and safety of somatropin (Omnitrope®) for the treatment of children requiring growth hormone treatment. Methods: PATRO Children is a multicentre, open, longitudinal, noninterventional study being conducted in children’s hospitals and specialised endocrinology clinics. The primary objective is to assess the long-term safety of Omnitrope® in routine clinical practice. Eligible patients are infants, children and adolescents (male or female) who are receiving treatment with Omnitrope® and who have provided informed consent. Patients who have been treated with another recombinant human growth hormone (rhGH) product before starting Omnitrope® are eligible for inclusion. All adverse events (AEs) are monitored and recorded, with particular emphasis on: long-term safety; the recording of malignancies; the occurrence and clinical impact of anti-hGH antibodies; the development of diabetes during Omnitrope® treatment in children short for gestational age (SGA); safety issues in patients with Prader–Willi syndrome (PWS). Efficacy assessments include auxological parameters, plus insulin-like growth factor-1 and insulin-like growth factor binding protein-3. Results: As of September 2012, 1837 patients were enrolled in the study from 184 sites in 10 European countries. To date, efficacy data are reassuring and consistent with previous studies. In addition, there have been no confirmed cases of diabetes occurring under Omnitrope® treatment, no reports of malignancy and no safety issues in PWS patients. Conclusions: The efficacy and safety profile of Omnitrope® in the PATRO Children study so far are as expected. The ongoing study will extend the safety database for Omnitrope®, and rhGH products more generally, in paediatric indications. Of particular interest, PATRO Children will add important information on the diabetogenic potential of rhGH in children born SGA, the risk of malignancies in children receiving rhGH, and AEs with a possible causal relationship to rhGH treatment in children with PWS.
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O'Connor, R. J. "Postmarketing Surveillance for "Modified-Risk" Tobacco Products." Nicotine & Tobacco Research 14, no. 1 (January 20, 2011): 29–42. http://dx.doi.org/10.1093/ntr/ntq243.
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Vandenburg, M., and W. H. Inman. "Postmarketing surveillance Is not used to promote products." BMJ 309, no. 6954 (September 3, 1994): 608. http://dx.doi.org/10.1136/bmj.309.6954.608b.
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Massari, Marco, Stefania Spila Alegiani, Cristina Morciano, Matteo Spuri, Pasquale Marchione, Patrizia Felicetti, Valeria Belleudi, et al. "Postmarketing active surveillance of myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines in persons aged 12 to 39 years in Italy: A multi-database, self-controlled case series study." PLOS Medicine 19, no. 7 (July 28, 2022): e1004056. http://dx.doi.org/10.1371/journal.pmed.1004056.
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Background Myocarditis and pericarditis following the Coronavirus Disease 2019 (COVID-19) mRNA vaccines administration have been reported, but their frequency is still uncertain in the younger population. This study investigated the association between Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA vaccines, BNT162b2, and mRNA-1273 and myocarditis/pericarditis in the population of vaccinated persons aged 12 to 39 years in Italy. Methods and findings We conducted a self-controlled case series study (SCCS) using national data on COVID-19 vaccination linked to emergency care/hospital discharge databases. The outcome was the first diagnosis of myocarditis/pericarditis between 27 December 2020 and 30 September 2021. Exposure risk period (0 to 21 days from the vaccination day, subdivided in 3 equal intervals) for first and second dose was compared with baseline period. The SCCS model, adapted to event-dependent exposures, was fitted using unbiased estimating equations to estimate relative incidences (RIs) and excess of cases (EC) per 100,000 vaccinated by dose, age, sex, and vaccine product. Calendar period was included as time-varying confounder in the model. During the study period 2,861,809 persons aged 12 to 39 years received mRNA vaccines (2,405,759 BNT162b2; 456,050 mRNA-1273); 441 participants developed myocarditis/pericarditis (346 BNT162b2; 95 mRNA-1273). Within the 21-day risk interval, 114 myocarditis/pericarditis events occurred, the RI was 1.99 (1.30 to 3.05) after second dose of BNT162b2 and 2.22 (1.00 to 4.91) and 2.63 (1.21 to 5.71) after first and second dose of mRNA-1273. During the [0 to 7) days risk period, an increased risk of myocarditis/pericarditis was observed after first dose of mRNA-1273, with RI of 6.55 (2.73 to 15.72), and after second dose of BNT162b2 and mRNA-1273, with RIs of 3.39 (2.02 to 5.68) and 7.59 (3.26 to 17.65). The number of EC for second dose of mRNA-1273 was 5.5 per 100,000 vaccinated (3.0 to 7.9). The highest risk was observed in males, at [0 to 7) days after first and second dose of mRNA-1273 with RI of 12.28 (4.09 to 36.83) and RI of 11.91 (3.88 to 36.53); the number of EC after the second dose of mRNA-1273 was 8.8 (4.9 to 12.9). Among those aged 12 to 17 years, the RI was of 5.74 (1.52 to 21.72) after second dose of BNT162b2; for this age group, the number of events was insufficient for estimating RIs after mRNA-1273. Among those aged 18 to 29 years, the RIs were 7.58 (2.62 to 21.94) after first dose of mRNA-1273 and 4.02 (1.81 to 8.91) and 9.58 (3.32 to 27.58) after second dose of BNT162b2 and mRNA-1273; the numbers of EC were 3.4 (1.1 to 6.0) and 8.6 (4.4 to 12.6) after first and second dose of mRNA-1273. The main study limitations were that the outcome was not validated through review of clinical records, and there was an absence of information on the length of hospitalization and, thus, the severity of the outcome. Conclusions This population-based study of about 3 millions of residents in Italy suggested that mRNA vaccines were associated with myocarditis/pericarditis in the population younger than 40 years. According to our results, increased risk of myocarditis/pericarditis was associated with the second dose of BNT162b2 and both doses of mRNA-1273. The highest risks were observed in males of 12 to 39 years and in males and females 18 to 29 years vaccinated with mRNA-1273. The public health implication of these findings should be considered in the light of the proven mRNA vaccine effectiveness in preventing serious COVID-19 disease and death.
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Crowther, Mark. "Phase 4 research: what happens when the rubber meets the road?" Hematology 2013, no. 1 (December 6, 2013): 15–18. http://dx.doi.org/10.1182/asheducation-2013.1.15.
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Abstract Approval of a novel drug is oftentimes seen as the end of the development pathway. However, the appearance of rare but serious side effects in patients taking approved drugs has led to increased attention to phase 4, or postmarketing, research. Traditionally, postmarketing research relied on reports from clinicians to monitor for unexpected toxicity. However, such reporting will produce a biased assessment of risk due to underreporting of toxic effects in older medications. The availability of large, representative databases and more flexible analysis tools has led to comprehensive and near “real-time” surveillance programs. These programs have been used by the US Food and Drug Administration to explore toxicities of approved medications. The need for effective tools with which to monitor clinically relevant outcome events has been further increased by the development of accelerated pathways to drug approval. In areas without effective treatments, such pathways lead to licensure without rigorous clinical efficacy data. Continued approval is frequently made contingent on the availability of postmarketing surveillance data demonstrating improvements in clinical end points and these data can also be used to monitor for unexpected toxicity.
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Dickneite, Gerhard, Christine Joch, and Garrett E. Bergman. "The Evaluation of a Prothrombotic Risk in a Human Fibrinogen Concentrate." Blood 112, no. 11 (November 16, 2008): 4064. http://dx.doi.org/10.1182/blood.v112.11.4064.4064.
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Abstract Fibrinogen is a circulating coagulant protein which is converted to polymerizable fibrin by thrombin. The human fibrinogen concentrate (FC) (CSL Behring) has been used for the treatment of bleeding in fibrinogen deficiency. In this investigation we investigated the prothrombotic potential of FC using the in-vivo, Wessler venous stasis assay in rabbits Thrombogenicity in clinical use was assessed in a postmarketing drug surveillance review. Forty-five rabbits were randomized to receive either placebo or 40 mg/kg of one of four different lots of FC, injected into a marginal ear vein. Thirty seconds thereafter, a segment of the right jugular vein (1.5 – 2.0 cm) was ligated. After 15 minutes the segment was removed and evaluated for thrombus formation according to a score system from 0 –3. Thrombogenic materials, such as activated prothrombin complexes, have consistently shown high scores of thrombus formation in this assay. The mean score in the FC treated rabbits (0.85 ± 1.04) was not different from that in the placebo-treated rabbits (0.8 ± 0.84). Postmarketing data was comprised of spontaneous reports to a postmarketing surveillance system for Adverse Drug Reports (ADR). The number of ADR reports was expressed relative to the number of estimated single standard doses. The estimated dose per patient was adjusted to the degree of bleeding (between one to eight gram). Between January 01, 1986 and April 30, 2008 in total 983,195 g of Haemocomplettan® P had been distributed. Very few reports (n=9) of thromboembolic events have been reported throughout postmarketing surveillance, corresponding to one case report for every 13,655 treatments of 8 grams FC. The reported thromboembolic events occurred in patients with congenital afibrinogenemia or acquired hypofibrinogenemia. In most cases, patients had additional risk factors (e.g. concomitant administration of blood products prothrombin complex concentrate, platelet concentrates, activated factor VII, etc.). Although a causal relationship to administration of FC could not be definitely excluded, the occurrence of thromboembolic events is very rare. From congruent results of both a classical preclinical model of thrombogenicity and analysis of postmarketing data, FC appears to have a very low risk of thrombogenicity.
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Korberly, Barbara H., Katherine V. Mann, and Mary Joan C. Denisco. "Careers for Pharmacists in the Pharmaceutical Industry: Perspective on Medical Affairs." Journal of Pharmacy Practice 2, no. 2 (April 1989): 105–9. http://dx.doi.org/10.1177/089719008900200208.
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Pharmaceutical industry represents a potential career path for pharmacists. Industry positions currently available to pharmacists, particularly those for individuals with advanced degrees, are expanding. This article will focus on opportunities for career-oriented pharmacists within a medical department with particular reference to a pharmaceutical company that markets nonprescription drug products. Although the potential responsibilities with this area may vary between companies, this article will focus on the areas of drug information, adverse drug experience reporting, postmarketing surveillance, and medical writing. These topics have been selected because they represent some of the responsibilities of pharmacists within the Medical Affairs Department at McNeil Consumer Products Company, a member of the Johnson & Johnson Family of Companies. In addition to job-related responsibilities, the suitability of a pharmacy education along with potential rewards and frustrations of working within the pharmaceutical industry are also presented.
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Trojano, Maria, Maria Liguori, Damiano Paolicelli, Giovanni Bosco Zimatore, Francesca De Robertis, Carlo Avolio, Fabrizio Giuliani, Aurora Fuiani, and Paolo Livrea. "Interferon beta in relapsing-remitting multiple sclerosis: an independent postmarketing study in southern Italy." Multiple Sclerosis Journal 9, no. 5 (October 2003): 451–57. http://dx.doi.org/10.1191/1352458503ms948oa.
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This independent, population-based surveillance study monitored the efficacy and safety of interferon beta (IFNb) products in 1033 patients with relapsing -remitting multiple sclerosis (RRMS) from 15 centres in Italy. Relapses, Expanded Disability Status Scale (EDSS) scores, and adverse events were evaluated for up to 24 months. Data of patients with a baseline EDSS score 5-3.5 are reported. The proportions of relapse-free patients were similar among the groups at 12 and 24 months (P =0.10). IFNb products produced significant reductio ns from baseline in relapse rates at 12 and 24 months (P B-0.001), with no differences among treatments (P =0.2). There were no significant differences in mean EDSS change among groups at 12 or 24 months. The IFNb-1b group showed a higher incidence of adverse events during the first year of treatment (P B-0.05) than IFNb-1a groups, and more withdrawals (10%) compared with Avonex (5%) at 24 months. IFNb products are equally effective in low disability RRMS, but IFNb-1a may have a more favorable efficacy/tolerability ratio.
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Inciardi, PhD, James A., Hilary L. Surratt, PhD, Yamilka Stivers, BA, and Theodore J. Cicero, PhD. "FDA approvals of generic drugs: Impact on the diversion of opioid analgesics with a potential for abuse." Journal of Opioid Management 5, no. 2 (January 29, 2018): 81. http://dx.doi.org/10.5055/jom.2009.0009.
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Generic drugs account for half of all prescription drug purchases in the United States. Although they are bioequivalent to their branded counterparts, they are typically sold at substantial discounts from the branded price. Given this, the purpose of this analysis is to examine the impact of the introduction of generic forms of selected opioids on their diversion to the illicit marketplace. The analgesics in this analysis include oxycodone ER (extended release), and the fentanyl transdermal patch. The data were collected through a postmarketing surveillance initiative supported by the Researched Abuse Diversion and Addiction-Related Surveillance (RADARS®) System risk management program, gathered on a quarterly basis from a national sample of police and regulatory agencies. The results indicate that with oxycodone ER and the fentanyl transdermal patch, the diversion of their generic formulations occurs less often than that of the branded products, and that the introduction of the generic formulations did not significantly increase the overall levels of diversion during the period covered by this analysis. Although diversion did not increase in the short-term, the need for longer term monitoring appears warranted.
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Geoffrey Severtson, Stevan, Scott E. D. Kreider, Elise C. Amioka, Zachary R. Margolin, Janetta L. Iwanicki, and Richard C. Dart. "Postmarketing Analysis of Misuse, Abuse, and Diversion of Xtampza ER." Pain Medicine 21, no. 12 (October 23, 2020): 3660–68. http://dx.doi.org/10.1093/pm/pnaa272.
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Abstract Objective To evaluate abuse, misuse, and diversion of Xtampza ER, an extended-release (ER) abuse-deterrent formulation (ADF) of oxycodone. Methods Abuse, misuse, and diversion of Xtampza ER were assessed using Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System data sources. Xtampza ER was compared with immediate-release (IR) oxycodone, other ADF ER products combined, and non-ADF ER products combined. Results Xtampza ER prescriptions increased 50-fold during the study period. In contrast, cases from poison centers, substance abuse treatment centers, and diversion were infrequent and did not increase. Adjusted for prescriptions dispensed, poison center exposures were greater for IR oxycodone (rate ratio [RR] = 2.3, P = 0.008), other ADF ER opioids (RR = 5.2, P < 0.001), and non-ADF ER opioids (RR = 2.5, P = 0.004) than for Xtampza ER. In Treatment Center Programs Combined, past-month abuse prevalence for other ADF ER opioids (odds ratio [OR] = 7.4, P < 0.001) and non-ADF ER opioids (OR = 2.0, P = 0.002) was greater than Xtampza ER; IR oxycodone was not significantly different (OR = 1.2, P = 0.349). In the Drug Diversion Program, rates for IR oxycodone (RR = 3.7, P = 0.003), other ADF ER opioids (RR = 4.2, P = 0.002), and non-ADF ER opioids (RR = 3.4, P = 0.007) were greater than Xtampza ER. Adjustment using morphine equivalents provided similar results, except that IR oxycodone in Treatment Center Programs Combined became higher than Xtampza ER. Nonoral abuse cases involving Xtampza ER were infrequent; Web monitoring data support findings that Xtampza ER is difficult to abuse nonorally. Conclusion Xtampza ER abuse, misuse, and diversion and tampering are low relative to other prescription opioid analgesics. Abuse and diversion did not increase over the study period.
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Porter, Kim Maria Frances, Iain Parry Hargreaves, Stephen De Souza, and Rebecca Goddard. "Treatment with the direct oral anticoagulants (DOACs) apixaban and rivaroxaban associated with significant worsening of behavioural and psychological symptoms of dementia (BPSD)." BMJ Case Reports 14, no. 3 (March 2021): e240059. http://dx.doi.org/10.1136/bcr-2020-240059.
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We report the cases of two patients who developed worsening behavioural and psychological symptoms of dementia (BPSD), coinciding with starting the factor Xa inhibitor direct oral anticoagulant medications apixaban and rivaroxaban, respectively. Both patients required detaining under the Mental Health Act. Their symptoms improved significantly, within 2 weeks, on switching to alternative anticoagulant therapies and they were both discharged from the acute psychiatric ward. Front-line staff should partake in postmarketing surveillance of medications, completing the Medicines and Healthcare products Regulatory Agency yellow cards for example (UK). There is increasing evidence for an aetiological role of cerebral mitochondrial dysfunction in neuropsychiatric disorders. Development of a rating scale of drugs that are potentially less toxic to cerebral mitochondria could inform national prescribing guidelines and enable safer treatments to be offered to older people, reducing the likely hood of them experiencing apparent BPSD.
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Liang, Zuanji, Hao Hu, Junlei Li, Dongning Yao, Yitao Wang, and Carolina Oi Lam Ung. "Advancing the Regulation of Traditional and Complementary Medicine Products: A Comparison of Five Regulatory Systems on Traditional Medicines with a Long History of Use." Evidence-Based Complementary and Alternative Medicine 2021 (October 27, 2021): 1–16. http://dx.doi.org/10.1155/2021/5833945.
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Background. An appropriate regulatory system to ensure and promote the quality, safety, and efficacy of the products of traditional medicine (TM) and complementary medicine (CM) is critical to not only public health but also economic growth. The regulatory approach and evaluation standards for TM/CM products featured with a long history of use are yet to be developed. This study aims to investigate and compare the existing regulatory approaches for TM/CM products with a long history of use. Method. A mixed approach of documentary analysis involving official and legal documents from official websites, as well as a scoping review of scholarly work in scientific databases about regulatory systems of TM/CM products in China, Hong Kong, Taiwan, Japan, and Korea, was employed in this study and used for comparison. Results. For registration purposes, all five regulatory systems recognized the history of use as part of the totality of evidence when evaluating the safety and efficacy of TM/CM products with a long history of use. Generally, the list of classic formulas is predefined and bound to the formulas recommended in the prescribed list of ancient medical textbooks. Expedited pathways are usually in place and scientific data of nonclinical and clinical studies may be exempted. At the same time, additional restrictions with the scope of products constitute a comprehensive approach in the regulation. Quality assurance and postmarketing safety surveillance were found to be the major focus across the regulatory schemes investigated in this study. Conclusion. The regulatory systems investigated in this study allow less stringent registration requirements for TM/CM products featured with a long history of use, assuming safety and efficacy to be plausible based on historic use. Considering the safety and efficacy of these products, regulatory standards should emphasize the technical requirements for quality control and postmarket surveillance.
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Opoku, Solomon, and Isaac Nyanor. "Qualitative and Quantitative Microbiological Studies of Paediatric Artemether-Lumefantrine Dry Powders and Paracetamol Syrups Obtained from Selected Drug Stores in Accra, Ghana." Journal of Tropical Medicine 2019 (July 14, 2019): 1–13. http://dx.doi.org/10.1155/2019/7062016.
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Infants and children under five years generally have high susceptibility to pathogenic and opportunistic infections due to immaturity and inexperience of their immune responses. The lives of these young children are threatened when they consume pharmaceutical preparations of poor microbiological quality. Considering the widespread use of artemether-lumefantrine dry powder and paracetamol syrup among the general population in Ghana, there is a need to investigate the microbiological quality and safety of these paediatric pharmaceutical preparations. The study investigated the microbiological quality of 180 samples comprising 90 artemether-lumefantrine dry powders and 90 paracetamol syrups. The samples were tested for presence of specified indicator pathogens, Total Aerobic Microbial Count (TAMC), and Total Yeasts and Moulds Count (TYMC) using compendial procedures. Results from the study indicated that 16 (17.78%) of the paracetamol syrup samples showed bioburden levels above United States Pharmacopeia (USP) maximum acceptable limit, but none of the artemether-lumefantrine dry powder samples recorded microbial load above the limit of USP. Four samples of paracetamol syrup and 4 samples of artemether-lumefantrine dry powder showed presence of P. aeruginosa, whereas 5 samples of paracetamol syrup were found to be contaminated with Salmonella spp. Overall, 4.44% of the artemether-lumefantrine dry powders and 25.56% of the paracetamol syrups were found to be noncompliant with USP specifications for nonsterile pharmaceutical preparations for oral use. This study has revealed the existence of substandard paediatric pharmaceutical products in the Ghanaian market, hence the need for regulatory bodies to intensify monitoring and postmarketing surveillance programmes to help get rid of these products from the market.
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Heneghan, Carl J., Ben Goldacre, Igho Onakpoya, Jeffrey K. Aronson, Tom Jefferson, Annette Pluddemann, and Kamal R. Mahtani. "Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process." BMJ Open 7, no. 12 (December 2017): e017125. http://dx.doi.org/10.1136/bmjopen-2017-017125.
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IntroductionTransvaginal mesh devices are approved in the USA by the Food and Drug Administration (FDA), through the 510(k) system. However, there is uncertainty about the benefit to harm balance of mesh approved for pelvic organ prolapse. We, therefore, assessed the evidence at the time of approval for transvaginal mesh products and the impact of safety studies the FDA mandated in 2012 because of emerging harms.MethodsWe used FDA databases to determine the evidence for approval of transvaginal mesh. To create a ‘family tree’ of device equivalence, we used the 510(k) regulatory approval of the 1985 Mersilene Mesh (Ethicon) and the 1996 ProteGen Sling (Boston Scientific), searched for all subsequently related device approvals, and for the first published randomised trial evidence. We assessed compliance with all FDA 522 orders issued in 2012 requiring postmarketing surveillance studies.ResultsWe found 61 devices whose approval ultimately relied on claimed equivalence to the Mersilene Mesh and the ProteGen Sling. We found no clinical trials evidence for these 61 devices at the time of approval. Publication of randomised clinical trials occurred at a median of 5 years after device approval (range 1–14 years). Analysis of 119 FDA 522 orders revealed that in 79 (66%) the manufacturer ceased market distribution of the device, and in 26 (22%) the manufacturer had changed the indication. Only seven studies (six cohorts and new randomised controlled trial) covering 11 orders were recruiting participants (none had reported outcomes).ConclusionsTransvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years. Devices have inherited approval status from a few products. A publicly accessible registry of licensed invasive devices, with details of marketing status and linked evidence, should be created and maintained at the time of approval.
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Sunil, V., K. Mohit, and Butchi Raju Akondi. "The Increasing Demand for Skilled Professionals in the Field of Pharmacovigilance." Asian Journal of Pharmaceutical Research and Health Care 16, no. 2 (April 2024): 109–12. http://dx.doi.org/10.4103/ajprhc.ajprhc_85_24.
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ABSTRACT The pharmaceutical sector is experiencing rapid advancements in drug discovery, strict regulations, and a commitment to patient safety. This has led to an increased demand for skilled pharmacovigilance experts who can ensure the safety and effectiveness of medicinal products. Several factors contribute to this demand. The expanding pharmaceutical landscape leads to the need for thorough investigation of the safety profile of new medications and treatments. The increasing volume of pharmaceutical products also requires close monitoring for safety and efficacy. Strict regulatory requirements from global agencies further emphasize the need for a robust pharmacovigilance system. The industry’s focus on patient safety drives the demand for professionals who can effectively manage and analyze safety data. The rise of biologics and biosimilars presents additional challenges in monitoring and assessing safety profiles, creating a need for specialized expertise. Furthermore, the globalization of clinical trials and technological advancements, such as artificial intelligence (AI) and machine learning (ML), require experts who can integrate these tools into pharmacovigilance methods. There are certain skill sets that are crucial for pharmacovigilance professionals. These include regulatory knowledge, data analysis and interpretation, case processing, signal detection and risk management, medical and scientific expertise, communication skills, and technological proficiency. There are various career opportunities in pharmacovigilance, including pharmacovigilance officer, pharmacovigilance scientist, medical reviewer, pharmacovigilance team lead/manager, regulatory affairs specialist, and consultant and trainer. Future trends in the field include the convergence of AI and ML, the use of real-world evidence for postmarketing surveillance and drug safety monitoring, collaboration, and outsourcing for PV projects, and the need to tailor pharmacovigilance approaches to personalized medicine. In conclusion, the pharmaceutical industry’s evolution and commitment to patient safety have created a growing need for skilled professionals in pharmacovigilance. Investments in the development and education of these professionals are essential for the advancement of drug safety and public health.
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Sayed, Ahmed, Malak Munir, Sanam M. Ghazi, Mussammat Ferdousi, Satyam Krishan, Adnan Shaaban, Alma Habib, et al. "Cardiovascular toxicities associated with bispecific T-cell engager therapy." Journal for ImmunoTherapy of Cancer 12, no. 2 (February 2024): e008518. http://dx.doi.org/10.1136/jitc-2023-008518.
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BackgroundBispecific T-cell engagers (BTEs) are novel agents used to treat hematological malignancies. Early trials were underpowered to define cardiovascular adverse events (CVAE) and no large-scale studies systematically examined the CVAEs associated with BTEs.MethodsLeveraging the US Food and Drug Administration’s Adverse Event Reporting System-(FAERS), we identified the relative frequency of CVAEs after initiation of five BTE products approved by the Food and Drug Administration between 2014 and 2023 for the treatment of hematological malignancies. Adjusted reporting ORs (aROR) were used to identify disproportionate reporting of CVAEs with BTEs compared with background rates in the database. Fatality rates and risk ratios (RRs) for each adverse event (AE) were calculated.ResultsFrom 3668 BTE-related cases reported to FAERS, 747 (20.4%) involved CVAEs. BTEs as a class were associated with fatal CVAEs (aROR 1.29 (95% CI 1.12 to 1.50)), an association mainly driven by teclistamab (aROR 2.44 (95% CI 1.65 to 3.60)). Teclistamab was also associated with a disproportionate risk of myocarditis (aROR 25.70 (95% CI 9.54 to 69.23)) and shock (aROR 3.63 (95% CI 2.30 to 5.74)), whereas blinatumomab was associated with a disproportionate risk of disseminated intravascular coagulation (aROR 3.02 (95% CI 1.98 to 4.60)) and hypotension (aROR 1.59 (95% CI 1.25 to 2.03)). CVAEs were more fatal compared with non-CVAEs (31.1% vs 17.4%; RR 1.76 (95% CI 1.54 to 2.03)). Most CVAEs (83.3%) did not overlap with cytokine release syndrome.ConclusionIn the first postmarketing surveillance study of BTEs, CVAEs were involved in approximately one in five AE reports and carried a significant mortality risk.
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Li, Xiaoying, Xin Lin, Huiling Ren, and Jinjing Guo. "Ontological Organization and Bioinformatic Analysis of Adverse Drug Reactions From Package Inserts: Development and Usability Study." Journal of Medical Internet Research 22, no. 7 (July 20, 2020): e20443. http://dx.doi.org/10.2196/20443.
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Background Licensed drugs may cause unexpected adverse reactions in patients, resulting in morbidity, risk of mortality, therapy disruptions, and prolonged hospital stays. Officially approved drug package inserts list the adverse reactions identified from randomized controlled clinical trials with high evidence levels and worldwide postmarketing surveillance. Formal representation of the adverse drug reaction (ADR) enclosed in semistructured package inserts will enable deep recognition of side effects and rational drug use, substantially reduce morbidity, and decrease societal costs. Objective This paper aims to present an ontological organization of traceable ADR information extracted from licensed package inserts. In addition, it will provide machine-understandable knowledge for bioinformatics analysis, semantic retrieval, and intelligent clinical applications. Methods Based on the essential content of package inserts, a generic ADR ontology model is proposed from two dimensions (and nine subdimensions), covering the ADR information and medication instructions. This is followed by a customized natural language processing method programmed with Python to retrieve the relevant information enclosed in package inserts. After the biocuration and identification of retrieved data from the package insert, an ADR ontology is automatically built for further bioinformatic analysis. Results We collected 165 package inserts of quinolone drugs from the National Medical Products Administration and other drug databases in China, and built a specialized ADR ontology containing 2879 classes and 15,711 semantic relations. For each quinolone drug, the reported ADR information and medication instructions have been logically represented and formally organized in an ADR ontology. To demonstrate its usage, the source data were further bioinformatically analyzed. For example, the number of drug-ADR triples and major ADRs associated with each active ingredient were recorded. The 10 ADRs most frequently observed among quinolones were identified and categorized based on the 18 categories defined in the proposal. The occurrence frequency, severity, and ADR mitigation method explicitly stated in package inserts were also analyzed, as well as the top 5 specific populations with contraindications for quinolone drugs. Conclusions Ontological representation and organization using officially approved information from drug package inserts enables the identification and bioinformatic analysis of adverse reactions caused by a specific drug with regard to predefined ADR ontology classes and semantic relations. The resulting ontology-based ADR knowledge source classifies drug-specific adverse reactions, and supports a better understanding of ADRs and safer prescription of medications.
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Wang, Xuan, Vidul Ayakulangara Panickan, Tianrun Cai, Xin Xiong, Kelly Cho, Tianxi Cai, and Florence T. Bourgeois. "Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices." JAMA Internal Medicine, August 21, 2023. http://dx.doi.org/10.1001/jamainternmed.2023.3562.
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ImportanceThe US Food and Drug Administration (FDA) is building a national postmarketing surveillance system for medical devices, moving to a “total product life cycle” approach whereby more limited premarketing data are balanced with postmarketing surveillance to capture rare adverse events and long-term safety issues.ObjectiveTo assess the methodological requirements and feasibility of postmarketing device surveillance using endovascular aneurysm repair devices (EVARs), which have been the subject of safety concerns, using clinical data from a large health care system.Design, Setting, and ParticipantsThis retrospective cohort study included patients with electronic health record (EHR) data in the Veterans Affairs Corporate Data Warehouse.ExposureImplantation of an AFX Endovascular AAA System (AFX) device (any of 3 iterations) or a non-AFX comparator EVAR device from January 1, 2011, to December 21, 2021.Main Outcomes and MeasuresThe primary outcomes were rates of type III endoleaks and all-cause mortality; and rates of these outcomes associated with AFX devices compared with non-AFX devices, assessed using Cox proportional hazards regression models and doubly robust causal modeling. Information on type III endoleaks was available only as free-text mentions in clinical notes, while all-cause mortality data could be extracted using structured data. Device-specific information required by the FDA is ascertained using unique device identifiers (UDIs), which include factors such as model numbers, catalog numbers, and manufacturer-specific product codes. The availability of UDIs in EHRs was assessed.ResultsIn total, 13 941 patients (mean [SD] age, 71.8 [7.4] years) received 1 of the devices of interest (AFX with Strata [AFX-S]: 718 patients [5.2%]; AFX with Duraply [AFX-D]: 404 patients [2.9%]; or AFX2: 682 patients [4.9%]), and 12 137 (87.1%) received non-AFX devices. The UDIs were not recorded in the EHR for any patient with an AFX device, and partial UDIs were available for 19 patients (0.1%) with a non-AFX device. This necessitated the development of advanced natural language processing tools to define the cohort of patients for analysis. The study identified a significantly higher risk of type III endoleaks at 5 years among patients receiving any of the AFX device iterations, including the most recent version, AFX2 (11.6%; 95% CI, 8.1%-15.1%) compared with that among patients with non-AFX devices (5.7%; 95% CI, 2.2%-9.2%; absolute risk difference, 5.9%; 95% CI, 2.3%-9.4%). However, there was no significantly higher all-cause mortality for any of the AFX device iterations, including for AFX2 (19.0%; 95% CI, 16.0%-22.0%) compared with non-AFX devices (18.0%; 95% CI, 15.0%-21.0%; absolute risk difference, 1.0%; 95% CI, −2.1% to 4.1%).Conclusions and RelevanceThe findings of this cohort study suggest that clinical data can be used for the postmarketing device surveillance required by the FDA. The study also highlights ongoing challenges to performing larger-scale surveillance, including lack of consistent use of UDIs and insufficient relevant structured data to efficiently capture certain outcomes of interest.
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Banach, Maciej, Niki Katsiki, Gustavs Latkovskis, Dan Gaita, Carlos Escobar, Daniel Pella, Peter E. Penson, Federica Fogacci, Željko Reiner, and Arrigo FG Cicero. "2024 Update on Postmarketing Nutrivigilance Safety Profile: A Line of Dietary Food Supplements Containing Red Yeast Rice for Dyslipidemia." Archives of Medical Science, June 16, 2024. http://dx.doi.org/10.5114/aoms/190111.
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IntroductionConsidering lack of a European standardized postmarketing food supplement surveillance system, some member states and companies have developed their own approaches to monitoring potential AEs to secure a high level of product safety. This paper updates 2021 results of the use of a nutrivigilance system in monitoring the incidence of spontaneously reported suspected AEs associated with RYR-containing food supplements.Material and methodsWe report the data from a product marketed under the trademark Armolipid/Armolipid Plus. Postmarketing information was collected in a voluntary nutrivigilance system established by the manufacturing company (Meda Pharma SpA, a Viatris Company, Monza, Italy). From 1st October 2004-31st December 2023, this system captured cases of suspected AEs spontaneously reported by consumers, healthcare professionals, health authorities, regardless of causality.ResultsThe total number of case reports received mentioning the RYR-food supplement product line increased to 1186, in which 1904 AEs were reported. The total reporting rate of AEs was estimated to be 0.049% of 3,880,865 exposed consumers. Of the 1186 cases, 28 (0.0007%) included suspected SAEs. After careful investigation, 9 cases (0.0002%) and 12 AEs were assessed by the manufacturer as serious and potentially related to exposure to the above-mentioned RYR-based nutraceutical. Off-label reports linked to the newly introduced limitation at 70 years of age were observed, in contrast to the previous analysis.ConclusionsThese updated results confirm a very low incidence of RYR suspected AEs. Consumer safety of food supplements could be generally improved by raising awareness of the importance of following the indications and warnings detailed in a food supplement’s labelling.
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Shinde, Shraddha, and Stephanie Y. Crawford. "The Science of Safety – An Emerging Concept in Medication Use and Research." INNOVATIONS in pharmacy 7, no. 3 (October 11, 2016). http://dx.doi.org/10.24926/iip.v7i3.445.
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Most published reports of patient safety in clinical practice focus largely on the culture of safety in complex health systems, separate from pre-approval and postmarketing research-related safety considerations for drugs, biologics, and other medical products. The science of safety requires a linked integrated perspective, i.e., an iterative process examining and relating safety concerns from drug or biologic discovery and development in preclinical stages, clinical trials and post-market use, research, surveillance, and potential regulatory changes. This commentary addresses the science of safety across the lifecycle of drug and biological products, regulatory considerations, barriers, and research needs. This paper provides a brief overview on how the functioning of healthcare systems affects the safety environment and describes how stakeholder involvement, research participation, and targeted education and training can help facilitate better safety measures and practices, provide improved quality of care to patients, and contribute to the science of safety.
Conflict of Interest
We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received), employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties".
Type: Commentary
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Ehrenzweig, Joel, and James St Clair. "Innovative Nutraceutical Effectively Manages Canine Atopy." Journal of Clinical Medical Research 03, no. 03 (2022). http://dx.doi.org/10.46889/jcmr.2022.3310.
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Like people, dogs may be allergic to numerous substances that their bodies touch or are found in the air or in food. These allergens enter the body by inhalation, direct contact or absorption, i.e., through the skin or respiratory or gastrointestinal tracts. Recognized as foreign entities, the canine response is the release of inflammatory cells and the regulation of histamine levels as defence mechanisms. Innumerable prescription and over-the-counter treatments have been advanced in attempts to relieve the clinical signs associated with canine seasonal allergies. The primary aim of this multisite, prospective open label trial was to support anecdotal postmarketing surveillance reports that the non-prescription canine chew under study provided significant benefits for the treatment of canine allergic dermatitis. A secondary aim was to elicit responses from groomers and pet parents who used the product for their dogs. Animals presented at random with lesions consistent with a diagnosis of allergic dermatitis were enrolled during the normal course of business at the veterinary hospital and groomers’ shops. Pet parents, groomers and veterinarians reported that a twice-a-day treatment regimen resulted in the reduction or alleviation of one or more cardinal signs of canine allergic dermatitis in 83.3% of the enrolled dogs. These findings warrant the use of Dermabliss Seasonal Allergy Chews alone or in conjunction with other treatments) for dogs with allergic dermatitis.
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Pokar, Dhruvisha, Amit Kumar Sahu, and Pinaki Sengupta. "LC-Q-TOF-MS driven identification of potential degradation impurities of venetoclax, mechanistic explanation on degradation pathway and establishment of a quantitative analytical assay method." Journal of Analytical Science and Technology 11, no. 1 (December 2020). http://dx.doi.org/10.1186/s40543-020-00252-4.
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AbstractVenetoclax is a selective orally active Bcl-2 protein inhibitor very recently approved by USFDA to treat chronic lymphocytic leukemia and other hematological malignancies. Postmarketing surveillance of any drug depends on its acceptability based on risk to benefit ratio. When risk outweighs the benefits, withdrawal of an already marketed drug is warranted. Presence of impurity is the primary cause of increased risk in a drug substance or drug product. With the discovery of newer molecules, it is of great importance to establish advanced analytical techniques for quantification of the drugs as well as their related impurities to address the prospective regulatory queries even if it is already in the market. In this study, a quantitative analytical assay method has been developed and validated for quantification of venetoclax in presence of its degradation impurities. A stress study was performed to examine the stability of the drug in hydrolytic, oxidative, thermolytic and photolytic environments. Venetoclax was found to be prone to degradation in acidic hydrolytic and oxidative stress conditions. Three new degradation impurities have been identified and characterized with the help of LC-Q-TOF-MS with accurate mass measurement and their putative structures have been proposed. Furthermore, for the first time, a possible degradation pathway has been established with mechanistic explanation. Moreover, the analytical method developed in this study will be of immense help for routine analysis of quality control and stability study samples of venetoclax in industry and research laboratories.
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Lombardo, Márcia. "Rotulagem de medicamentos industrializados: uma análise das diretrizes legais brasileiras e contribuições para a qualidade de produtos." Revista de Administração em Saúde 20, no. 81 (December 27, 2020). http://dx.doi.org/10.23973/ras.81.225.
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RESUMOObjetivos: a rotulagem é um aspecto de qualidade fundamental no uso de medicamentos, seja pelo profissional de saúde, seja pelo paciente. Este trabalho propôs uma análise crítica do tema com base na legislação em vigor, bem como a triagem de documentos normativos úteis no processo de elaboração ou de avaliação da conformidade da rotulagem de medicamentos. Métodos: foi realizada uma pesquisa documental empregando-se como fonte de informações os sítios eletrônicos oficiais do Ministério da Saúde e da Agência Nacional de Vigilância Sanitária. Os documentos contendo itens pertinentes a rotulagem de medicamentos e classificados como vigentes ou vigentes com alteração foram selecionados para a realização do estudo. Resultados: os quesitos mais relevantes das disposições gerais e das disposições específicas da norma vigente para rotulagem de medicamentos foram sistematizados, verificando-se suas contribuições na qualidade e segurança de produtos. Embora a padronização da rotulagem de medicamentos seja necessária, a ocorrência de elevados graus de semelhança entre rótulos, embalagens ou mesmo nomenclaturas é discutida no âmbito da prática clínica e esta questão merece atenção especial. A busca de material complementar à legislação vigente resultou no levantamento de um total de 20 documentos, incluindo normas, guias, bancos de consulta e planilhas, que podem auxiliar no cumprimento dos requisitos de rotulagem de medicamentos. Conclusão: rótulos de medicamentos são recursos técnicos que contribuem na eficácia e na segurança do tratamento. Os esforços das Agências Reguladoras têm permitido a consolidação de diretrizes legais para que informações e formatos adequados de rotulagem sejam aplicados nas embalagens de medicamentos industrializados. A elaboração ou a análise da rotulagem de medicamentos requer amplo conhecimento regulatório, o qual é dinâmico e, portanto, um grande desafio.Palavras-chave: Rotulagem de Medicamentos. Legislação de Medicamentos. Vigilância de Produtos Comercializados. Segurança do Paciente. ABSTRACTObjectives: the labeling of drug products is an aspect of quality that is fundamental to the use of medicines, whether by the health professional or by the patient. This work proposed a critical analysis of the current legislation on the labeling of drug products, as well as the screening of normative documents useful for the process of preparing or assessing the conformity of labels. Methods: a documentary research was carried out using the official websites of the Ministry of Health and the National Health Surveillance Agency (Brazil) as sources of information. The documents containing relevant items on labeling of drug products and classified as current or current with changes were selected for the study. Results: the most important requirements of the general and specific provisions from the current legislation have been systematized, and their contributions to the quality and safety of products have been verified. Although the standardization of the labeling is necessary, the occurrence of high degrees of similarity between labels, packaging or even nomenclatures is discussed in the context of clinical practice and this issue deserves special attention. The search for material complementary to the current legislation resulted in the collection of a total of 20 documents, including normative documents, guides, databases and spreadsheets, which might help in complying with the requirements for the labeling of drug products. Conclusion: the labeling of drug products are technical resources that contribute to the effectiveness and safety of treatment. The efforts of the Regulatory Agencies have allowed the consolidation of legal provisions for the dissemination of appropriate information and labeling formats in the packaging of drug products. The drafting or analysis of the labels requires extensive regulatory knowledge, which is dynamic and, therefore, a great challenge.Keywords: Drug Labeling. Legislation, Drug. Product Surveillance, Postmarketing. Patient Safety.
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"Postmarketing surveillance - how should doctors get involved?" Drug and Therapeutics Bulletin 26, no. 23 (November 14, 1988): 89–91. http://dx.doi.org/10.1136/dtb.26.23.89.
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Clinical trials carried out before licensing new drugs are designed primarily to assess efficacy, but will give some indication of the adverse effects of the drug, particularly those that are dose-related. However, serious adverse effects are unlikely to be detected at this stage. Postmarketing surveillance is needed to identify such adverse effects, and any specific groups of patients who are at particular risk. The Committee on Safety of Medicines (CSM) increasingly requests manufacturers to undertake postmarketing surveillance on new products intended for wide and long-term use, but it cannot require this as a condition of licensing.
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Potnis, Kunal C., Joseph S. Ross, Sanjay Aneja, Cary P. Gross, and Ilana B. Richman. "Artificial Intelligence in Breast Cancer Screening." JAMA Internal Medicine, November 7, 2022. http://dx.doi.org/10.1001/jamainternmed.2022.4969.
Full textAbstract:
ImportanceContemporary approaches to artificial intelligence (AI) based on deep learning have generated interest in the application of AI to breast cancer screening (BCS). The US Food and Drug Administration (FDA) has approved several next-generation AI products indicated for BCS in recent years; however, questions regarding their accuracy, appropriate use, and clinical utility remain.ObjectivesTo describe the current FDA regulatory process for AI products, summarize the evidence used to support FDA clearance and approval of AI products indicated for BCS, consider the advantages and limitations of current regulatory approaches, and suggest ways to improve the current system.Evidence ReviewPremarket notifications and other publicly available documents used for FDA clearance and approval of AI products indicated for BCS from January 1, 2017, to December 31, 2021.FindingsNine AI products indicated for BCS for identification of suggestive lesions and mammogram triage were included. Most of the products had been cleared through the 510(k) pathway, and all clearances were based on previously collected retrospective data; 6 products used multicenter designs; 7 products used enriched data; and 4 lacked details on whether products were externally validated. Test performance measures, including sensitivity, specificity, and area under the curve, were the main outcomes reported. Most of the devices used tissue biopsy as the criterion standard for BCS accuracy evaluation. Other clinical outcome measures, including cancer stage at diagnosis and interval cancer detection, were not reported for any of the devices.Conclusions and RelevanceThe findings of this review suggest important gaps in reporting of data sources, data set type, validation approach, and clinical utility assessment. As AI-assisted reading becomes more widespread in BCS and other radiologic examinations, strengthened FDA evidentiary regulatory standards, development of postmarketing surveillance, a focus on clinically meaningful outcomes, and stakeholder engagement will be critical for ensuring the safety and efficacy of these products.