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Background: Many medicine quality problems are detected after they arrive at health facilities. Thus, critically defective medicines that may pose health risks to patients need to be withheld or recalled. Aims: To investigate the withheld and recalled medicines in relation to the types of defects, their total numbers, therapeutic categories, pharmaceutical dosage forms, and country of manufacturer during the study period. Methods: A retrospective review was performed on withheld and recalled medicines published on the publicly available National Medicines Regulatory Authority (NMRA) official website in Sri Lanka between June 2018 and August 2021. Details on substandard medicines (SM) were extracted and documented. Each record of SM was individually reviewed to determine the type of defect, subsequent action taken by NMRA, therapeutic category, pharmaceutical dosage form, and country of manufacturer. Results: A total of 163 defects were identified in 143 defective medicines, among which the most common types of defects were contamination (n = 59, 36.2%), stability defects (n = 41, 25.2%), packaging and labelling defects (n = 27, 16.6%) and active pharmaceutical ingredient defects (n = 26, 15.9%). Out of 143 total defective medicines identified, anti-infectives accounted for 41.9%, while parenteral preparations (44.0%) were found to be frequently defective. Nearly 70% of the recalled and withheld medicines were of Indian origin, and some manufacturers were identified to be repeatedly involved. Conclusions: This study revealed that contamination was the most frequent cause of defective medicines, while parenteral preparations and anti-infectives were the most susceptible pharmaceutical dosage form and therapeutic category found to be substandard, respectively. In addition, the findings show that some manufacturers were accountable for repetitive withholdings and recalls, which reflects the ignorance of quality control measures and weak regulatory inspections as a violation of Good Manufacturing Practice (GMP). [ABSTRACT FROM AUTHOR]

Background: The US Food and Drug Administration (FDA) regulates goods accounting for 20% of US consumers' total expenditure. The agency's potential susceptibility to corporate lobbying and political influence may adversely affect the its abilities to fulfill its duties as a vital federal agency. This study assesses whether the FDA's product recall classifications in recall scenarios are influenced by firms' lobbying activities. Methods: The universe of all FDA recalls between 2012 and 2019 is obtained from the FDA's website. Firm names are matched to federal-level lobbying data obtained from the Center for Responsive Politics – a non-profit and nonpartisan organization that tracks lobbying expenditures and campaign contributions. Analyses are conducted using ordinary-least-squares regressions, in which the dependent variable is recall classification and independent variables are three different measures of firms' lobbying activities in the one year prior to the recall. Results: Firms that engage in lobbying appear more likely to receive favourable classifications from the FDA. When examining the above results by product type, we find that classification of food recalls seems to be subject to lobbying influence, but the same does not appear to be true for drug and device recalls. Evidence is consistent with the conjecture that the distinction between medical and food firms may be a result of medical firms targeting lobbying efforts at FDA approvals, rather than recalls. Conclusions: Between 2012 and 2019, the FDA's product recall classifications seem to be significantly influenced by firms' lobbying activities. Lobbying firms appear to have received more favorable (i.e., less severe) recall classifications compared to non-lobbying firms. [ABSTRACT FROM AUTHOR]

Background: This study aims to investigate growing Internet use in relation to memory and cognition. Though literature reveals human capability to utilize the Internet as a transactive memory source, the formational mechanisms of such transactive memory systems are not extensively explored. The Internet's comparative effects on transactive memory and semantic memory are also relatively unknown. Methods: This study comprises two experimental memory task survey phases utilizing null hypothesis and standard error tests to assess significance of results. Results: When information is expected to be saved and accessible, recall rates are lower, regardless of explicit instructions to remember (Phase 1, N = 20). Phase 2 suggests the importance of order of attempted recall: depending on whether users first attempt to recall (1) desired information or (2) the information's location, subsequent successful cognitive retrieval is more likely to occur for (1) only desired information or both desired information and location thereof or (2) only desired information's location, respectively (N = 22). Conclusions: This study yields several theoretical advances in memory research. The notion of information being saved online and accessible in the future negatively affects semantic memory. Phase 2 reveals an adaptive dynamic—(1) as Internet users often have a vague idea of desired information before searching for it on the Internet, first accessing semantic memory serves as an aid for subsequent transactive memory use and (2) if transactive memory access is successful, the need to retrieve desired information from semantic memory is inherently eliminated. By repeatedly defaulting to first accessing semantic memory and then transactive memory or to accessing transactive memory only, Internet users may form and reinforce transactive memory systems with the Internet, or may refrain from enhancing and decrease reliance on transactive memory systems by repeatedly defaulting to access only semantic memory; the formation and permanence of transactive memory systems are subject to users' will. Future research spans the domains of psychology and philosophy. [ABSTRACT FROM AUTHOR]

Background: Even with all the care taken during the production process, the pharmaceutical industries are still subject to manufacturing medicines with quality deviations, generating commercialized products without the required quality and necessitating their subsequent recall from the market. The objective of this study was to evaluate the reasons that led to the recall of medicines in Brazil in the period evaluated. Methods: This is a descriptive study (using document analysis), on the recall of substandard medicines registered on the website of the National Health Surveillance Agency (ANVISA), from 2010 to 2018. The variables studied were the type of medicine (reference, generic, similar, specific, biological, herbal, simplified notification, new and radiopharmaceutical), type of pharmaceutical dosage form (solid, liquid, semi-solid and parenteral preparation), and reason for recall (Good manufacturing practices, quality and quality/good manufacturing practices). Results: A total of n = 3,056 recalls of substandard medicine were recorded. Similar medicines had a higher recall index (30.1%), followed by generics (21.3%), simplified notification (20.7%) and reference (12.2%). Different dosage forms had similar recalls: solids (35.2%), liquids (31.2%) and parenteral preparations (30.0%), with the exception of semi-solids (3.4%). The reasons for the highest occurrences were related to good manufacturing practices (58.4%) and quality (40.4%). Conclusion: The probable cause for this high number of recalls is the fact that, even with all the quality controls and processes in accordance with good manufacturing practices, errors can occur, both human and in automated processes, thus causing the release of batches that should not have been approved. In summary, it is necessary for manufacturers to implement a robust and well structured quality system in order to avoid such deviations, and it is up to ANVISA to apply greater oversight in the post marketing of these products. [ABSTRACT FROM AUTHOR]

Camrelizumab (SHR-1210) is a humanized IgG4 monoclonal anti-programmed cell death protein 1 (PD-1) antibody that has been shown to inhibit the binding of PD-1 to PD-L1, thereby blocking the immune escape of various types of cancer, including lung squamous cell carcinoma (LSCC). Reactive cutaneous capillary endothelial proliferation (RCCEP) is the most common adverse event in camrelizumab-treated patients. Here, we introduce a case of LSCC with recall RCCEP induced by stereotactic body radiation therapy (SBRT). A 76-year-old LSCC patient developed RCCEP when he received camrelizumab and chemotherapy. After discontinuing camrelizumab treatment, the RCCEP lesions spontaneously regressed and fell off. However, when the patient received subsequent SBRT, the RCCEP occurred again at the same sites. This case may provide clues for additional study of the immune reactivation effect of SBRT or the underlying mechanism of RCCEP. [ABSTRACT FROM AUTHOR]

Background: Older cancer patients may search for health information online to prepare for their consultations. However, seeking information online can have negative effects, for instance increased anxiety due to finding incorrect or unclear information. In addition, existing online cancer information is not necessarily adapted to the needs of older patients, even though cancer is a disease often found in older individuals.Objective: The aim of this study was to systematically develop, implement and evaluate an online health information tool for older cancer patients, the Patient Navigator, providing information that complements the consultation with healthcare providers.Method: For the development and evaluation of the Patient Navigator, the four phases of the MRC framework were used. In the first and second phase the Patient Navigator was developed and pilot tested based on previous research and sub-studies. During the third phase the Patient Navigator was implemented in four Dutch hospitals. In the last phase, a pilot RCT was conducted to evaluate the Patient Navigator in terms of usage (observational tracking data), user experience (self-reported satisfaction, involvement, cognitive load, active control, perceived relevance of the tool), patient participation (observational data during consultation), and patient outcomes related to the consultation (questionnaire data regarding anxiety, satisfaction, and information recall). Recently diagnosed colorectal cancer patients (N = 45) were randomly assigned to the control condition (usual care) or the experimental condition (usual care + Patient Navigator).Results: The Patient Navigator was well used and evaluated positively. Patients who received the Patient Navigator contributed less during the consultation by using less words than patients in the control condition and experienced less anxiety two days after the consultation than patients in the control condition.Conclusion: Since the Patient Navigator was evaluated positively and decreased anxiety after the consultation, this tool is potentially a valuable addition to the consultation for patients. Usage of the Patient Navigator resulted in patients using less words during consultations, without impairing patients' satisfaction, possibly because information needs might be fulfilled by usage of the Patient Navigator. This could create the possibility to personalize communication during consultations and respond to other patient needs. [ABSTRACT FROM AUTHOR]